Working at Aptalis

Employment Opportunities in Canada

Project Management Officer (ITS)
Mon, 23 Apr 2012 18:56:45 GMT

Reporting to the Executive Director, Information Technology & Solutions, t he PMO coordinates project and program (status, progress, budget) information across all the IT activities. He coordinates with the Business Analysts to maintain an overall view of the project activities and ensures alignment with business objectives and priorities. The role is also responsible for developing a robust and flexible project and program methodology for use throughout the IT organization, as well as track overall IT spend.  ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Manages the consolidation of  status reporting (tasks & spend) for a portfolio of project and other activities for the IT team. Ensures that initiatives in project management services are aligned with business strategy and priorities. Collaborates with Executive Director, Business Analysts, and Architects to develop and coordinate project and program budgeting, cost estimation approaches, resource allocation, and reallocations. Prioritizes programs and projects based on changing functional needs, resource capacity constraints, risk exposure, and interdependencies. Monitors value metrics to inform decisions that maximize returns across enterprise projects and programs. Works with Business Analysts to develop project and program resourcing strategies to ensure optimum support for projects and for the day-to-day operational activities. Ensures adoption and implementation of project and program management methodology. Communicates status of the project and program portfolio to all stakeholders in business units and head of multifunctional shared services group. Defines principles and standards to harmonize project management methodologies from third party or external service providers. Coordinates and plans meetings of a cross functional team of business unit representatives (ITS Steering Committee) to prioritize and track the portfolio of IT projects. Supervisory responsability No direct reports. Act as team coordinator for the Business Analysts   REQUIREMENTS   Bachelor’s degree in Computer Science, Business Administration or related area. A minimum of 5 to 7 years of experience in the IT industry including experience in business process development, team coordination, project management and project implementation. Knowledge of the pharmaceutical industry is an asset. Excellent organization and team collaboration skills; Excellent facilitation, collaboration, negotiation, and presentation skills; Strong project management skill s; Ability to anticipate risks and escalate appropriately; Ability to adapt quickly to new techn ologies and changing business requirements; Good understanding of the various development lifecycles  (e.g. Agile, RUP, and Waterfall); Excellent spoken and written communications skills with the Company’s various internal and external stakeholders; General knowledge of IT technologies, including Web, ERP and data management; Skilled with MS-Office, MS-Project and Visio; Excellent command of French and English, both spoken and written; Ability highlighted by interpersonal skills and the capability of obtaining consensus; Excellent planning and organizing of work; Capability of setting priorities according to schedules; The facility to adapt to a fast changing environment; Capability to work under pressure; Demonstrates initiative and innovation.

Employment Opportunities in the United States

Pharmaceutical Sales Specialist
Tue, 15 May 2012 15:51:50 GMT

PHARMACEUTICAL SALES SPECIALIST - WESTERN VA JOB SUMMARY The Pharmaceutical Sales Specialist is responsible for managing the business of an assigned sales territory and meeting or exceeding sales objectives for that territory. This position makes day-to-day decisions on sales calls, territory management and administration, handling customer service issues and opportunities, and implementing marketing plans. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Creates call plans and makes effective sales calls on healthcare professionals and their staffs providing current, accurate, company-approved product information to physicians, nurses, pharmacists and other classes of customers. •  Makes judgments about the appropriate message for each healthcare provider, including decisions about which products to discuss, frequency of calls and which approved materials to use during the call. Prepares for sales calls in advance by planning specific objectives, including an effective opening. Assesses the practitioner’s individual needs, determines how the products can meet the practitioner’s needs, and positions the product features and patient and practitioner benefits to satisfy practitioner and patient needs.  Answers questions or objections, provides fair balance and closes by asking for the business. •  Decides what types of interactions and educational opportunities will maximize the prescribing of Aptalis products. Effectively executes sales tactics, including the building of relationships within the practitioner community, such as arranging breakfasts and lunches at medical offices, conducting speaker programs, supporting events and community outreach programs, and participating in key industry meetings. •  Analyzes data provided by Aptalis, prescribing trends, competition and provider habits to customize the sales tactics and strategy, thereby maximizing the effectiveness of each call. •  Formulates and implements strategies for increasing the sales and market share of products including participation in creative sessions as part of the Marketing Advisory Board Committee; formulates and prepares the market for new product launches, and implements new product launches. •  Develops creative techniques, within compliance guidelines, to overcome access challenges and bring products to customers' attention. •  Builds relationships with pharmacy directors at hospitals, market and trade relations, members of the Pharmacy and Therapeutics Committee, and influential members of the medical community and works with them to add Aptalis' products to the hospital formulary. •  Works with pharmacists to solve managed health care issues. •  Seeks out knowledge of competitive products and activities and uses such market intelligence to increase sales; provides feedback of market intelligence to Aptalis management, including evaluating and sharing competitor information. •  Identifies "Key Opinion Leader" physicians for Aptalis products to speak at promotional dinner programs, and helps to identify additional health care professionals to develop as Aptalis approved speakers. •  Completes Daily Call Reports, maintaining accurate and current records of physicians, clinics, customer calls and outlining achievements, observations, suggestions, needs and summaries of call objectives. •  Completes timely Prescription Drug Marketing Act (PDMA) sample reconciliation reports, itineraries, expense reports and other administrative reports; inventorying, maintaining and appropriately using samples according to Company policy. •  Employs safe driving techniques and maintains the Company car according to the Aptalis Fleet Service Guide. •  Prepares for, attends and actively participates in Company sales and training meetings, including initial sales training. •  Manages budget to maximize sales and accomplish goals while achieving the highest return on investment. •  Implements or participates in approved and compliant preceptorship programs. •  Researches, reads, and studies medical literature to improve product knowledge in order to increase sales effectiveness; dissects and summarizes technical scientific reprints on specialty issues and discusses the findings of company-approved clinical reprints with medical professionals. •  Works well with others, listens to and values others' opinions; meets all deadlines and responsibilities and helps Regional Sales Manager meet region’s goals; welcomes newcomers and promotes a team atmosphere. •  Applies the highest possible standard of business ethics and behaves consistently with the Company’s values; is widely trusted and seen as a direct, truthful individual; is regular and predictable in attendance; can present the truth in an appropriate and helpful manner by keeping confidences, admitting mistakes and does not misrepresent him/herself for personal gain. •  Effectively adapts when faced with changing situations, unexpected pressures, and varying job demands; understands and appreciates different and opposing perspectives on an issue; supports and manages change initiatives. •  Maintains a neat and professional appearance at all business functions. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including but not limited to the Commercial Compliance Policy, Professional Conduct Policy and Prohibition Against Harassment Policy and the Business Ethics and Conduct Code. •  Must have the ability to complete an assigned task in a safe manner and in a constant state of alertness. •  Must be able to work in a cooperative manner with co-workers, supervisors, managers, doctors, health care workers and others. •  Works effectively under production and sales deadlines. SUPERVISOR RESPONSIBILITY This position has no supervisory responsibility. ESSENTIAL EDUCATION, EXPERIENCE, TECHNICAL SKILLS, AND QUALIFICATIONS Education and/or Experience Bachelor’s degree from four-year accredited college or university plus a minimum of two years pharmaceutical or related healthcare experience required. Licenses or Certifications Possess a valid driver’s license in the Pharmaceutical Sales Representative’s state of residence and maintain a driving record that is acceptable to the Company. Working Conditions Ability to travel, including overnight travel, by air and / or automobile, through the assigned territory, work long hours when necessary and work away from home for extended periods, to call on cystic fibrosis centers, non-center CF specialists, Gastroenterologists, Hepatologists, and other Specialists and Hospitals as appropriate. Qualifications •  Ability to meet and exceed sales goals, including the ability to formulate and successfully implement business plans, sales plans and sales calls. •  Ability to recognize internal and external customer needs and successfully position Aptalis Pharma products as solutions to customers’ needs. •  Ability to meet customer expectations and requirements on a timely basis. •  Ability to work independently and manage time effectively without close supervision. •  Must have the capability to make effective and persuasive speeches and presentations on complex topics to key audiences, i.e., physicians, caregivers and patients/parents. •  Proven ability to effectively interface and work cooperatively with individuals of all levels, plus demonstrated oral and written communication skills. •  Ability to think on his/her feet and adapt quickly to respond to physician's questions and various situations. •  The ability to occasionally lift 50-60 lbs •  Proficient in E-mail. Internet use, Microsoft Word, Excel and PowerPoint •  High attention to detail and accuracy, a commitment to quality work, and the ability to deploy strengths and compensate for weakness.

Medical Science Liaison - West
Mon, 14 May 2012 18:59:48 GMT

MEDICAL SCIENCE LIAISON - WEST JOB SUMMARY The Medical Scientific Liaison (MSL) acts as scientific voice of the Company in the field, engaging in meaningful exchange with the scientific community in therapeutic areas of strategic interest. This position facilitates Phase 3b/4 and investigator-initiated studies; presents scientific information as needed; develops and maintains productive relationships with thought leaders; provides competitive intelligence and relevant new scientific findings; and participates in medical education and training.  ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Engages in meaningful exchange with the scientific community in therapeutic areas of stra-tegic interest. •  Stays current in the scientific literature, interprets and applies findings to our products. •  Discusses product attributes in the context of the scientific literature with academic sites, key option leaders (KOLs), other contributors to the scientific and medical community, and at conferences and similar events. •  Discusses and elicits relevant news in the disease states of interest and potential new uses of our products. •  Serves as conduit for accurate and updated clinical, scientific and medical information be-tween investigators, thought leaders and academic institutions and the Company's Clinical and Regulatory Affairs group. •  Acts as the primary clinical/scientific resource for information pertaining to disease state and Company's product(s) to ensure awareness and understanding. •  Participates in publication planning and review. •  Adheres to all Company and regulatory agency guidelines regarding scientific exchange and ethical conduct. •  Facilitates Phase 3b/4 and investigator-initiated studies (IIRs). •  Identifies opportunities for investigator-initiated studies both pro-actively and as a result of discussions with thought leaders. •  Initiates, coordinates and provides clinical study expertise to investigators to facilitate protocol development, grant approval, study conduct, and publication of results.  •  Presents scientific information. •  Develops presentation material as required. •  Presents scientific information about relevant disease states and product attributes to formu-lary committees, in conferences, and in medical education events. •  Develops and maintains productive relationships with the scientific community. •  Identifies and develops strong relationships with KOLs, local thought leaders and key aca-demic institutions and researchers. •  Recruits thought leaders into speaker bureaus as needed. •  Organizes and facilitates scientific advisory boards as requested. •  Provides competitive intelligence and relevant new scientific findings to the company. •  Identifies key decision-makers and thought leaders and communicate to MA department. •  Attends relevant scientific conferences and report relevant news. •  Actively seeks and elicits information about competitor activities and report to MA and Mar-keting department. •  Participates in training of field force and medical community. •  Serves as the key clinical resource to the regional sales team. •  Develops training material as requested. •  Provides clinical education and training to cross-functional teams. •  Attends scientific/medical/professional meetings for educational purposes and to provide support at the Company’s booth. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY None EDUCATION AND/OR EXPERIENCE Advanced scientific or clinical degree (NP, PharmD, PhD, MD) required. Plus, a minimum of 5-7 years working in the pharmaceutical industry in clinical or medical functions; experience in the strategic therapeutic fields preferred. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satis-factorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Highly articulate and persuasive during formal and informal presentations; able to convey complex, scientific ideas fluently to any audience (account executives or top tier opinion leaders, non-advocate audiences, internal sales, marketing or legal staffs, MHC). •  Has ability to persuasively present approved information to all customer physicians, clinical pharmacists, healthcare key decision maker(s) consistent with Company policy •  Possesses doctorate level scientific knowledge and professional demeanor to earn and maintain the respect of health care professionals. •  Actively listens to others and is adept at confidently stating expert opinion while respecting the positions of others as well.  Can exert diplomacy while standing firm on a position. •  Ability to work effectively within cross-functional teams resulting in timely outcomes in support of business objectives. •  Possesses clear understanding of local medical practice and clinical decision making in re-gards to patient care. •  Ability to identify the unmet medical, educational, and research needs within the local medical community. •  Ability to interpret key scientific data and to translate this information to meet educational and research needs. •  Demonstrates ability to address educational and research needs through delivery of cutting edge scientific/evidenced based data. •  Understands healthcare systems affecting patient care, and the design and execution of re-search studies. •  Ability to think strategically. •  Has an established/respected track record of effective and persuasive oral presentations within the healthcare profession. •  Experience administering or positioning drug therapies.  

Specialist, Project Management
Mon, 14 May 2012 18:59:29 GMT

SPECIALIST, PROJECT MANAGEMENT JOB SUMMARY The incumbent is primarily responsible for the coordination of various project teams, functional sub-teams and project oversight committee meetings and activities per previously established processes, schedules and guidelines, in partnership with the Project Manager.  ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Participates in the coordination of meeting agendas, presentations and meeting minutes compilation utilizing suitable templates for the purpose.  Follows-up as necessary with essential team members in order to ensure timely availability of aforementioned materials. •  Coordinates the timely creation, update and distribution of various project meetings logs in partnership with the Project Manager, for example, actions log, decisions log, issues log, and risks log. •  Optimizes and supports the integrity of project team communications per established communication plans.  Proactively follows-up identified project-related issues seeking a quick resolution thereof. •  Helps with consolidation of the monthly project status reports and coordinates their distribution to identified leaders via agreed mechanisms. •  Serves as the central person responsible for the oversight of existing as well as newly created/integrated Project Management tools, processes/flow-charts and practices.  May be assigned super-user and/or trainer status for such tools/processes identified from time-to-time. •  Exhibits proficiency in working with the different Project Management tools, processes and procedures that are both established as well as to be newly created, consolidated or harmonized. •  Participates in the creation, update and/or oversight of all essential Project Management databases ensuring seamless access and functioning at all times to all identified team members. Some examples include Project Platform (integrated database for storage of project and project team meetings-related information), XRM (web-based tool helpful to create project status reports), TIMAX (time-reporting software), and other essential shared drives. •  Coordinates the logistical details necessary for holding identified meetings to ensure a smooth and efficient functioning thereof.  This includes but is not limited to scheduling, confirming, follow-up of attendance, document preparation, room and equipment availability, etc. •  Coordinates the review, finalization and distribution of post-meeting materials per established channels and processes to the core and extended team members, in a timely and consistent manner, including additional follow-ups as may be deemed essential. •  Provides support to non-project related tasks as may be requested from time-to-time, for example, those related to budget management, R&D payments, and miscellaneous integration-related activities. •  Carries out functional organization administrative tasks as requested from time-to-time such as sorting, filing, scanning and organizing project-related documents in an orderly fashion. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under deadlines. SUPERVISORY RESPONSIBILITIES None EDUCATION AND/OR EXPERIENCE Bachelors Degree in a scientific related field combined with 2-4 years experience in the pharmaceutical industry in a comparable function is preferred.  Any direct or indirect Project Management functional experience as well as a certification in Project Management constitutes an asset. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Proven track record of organizational, interpersonal, prioritization and multi-tasking skills •  Able to adapt to a fast changing, rapidly evolving environment •  Exhibits sound judgment, analytical acumen and concern for detail under pressure •  Respects and understands tight schedules and ensures follow-ups as essential •  Ability to work under direction with a fair bit of autonomy  •  Excellent command of oral and written English language that enables quality communications with various stakeholders, both inside as well as outside the Company •  Ability to maintain confidentiality, discretion, tact and diplomacy in all aspects of work •  Excellent command of Microsoft Office (including Word, Excel, Powerpoint, Access, Outlook and Project), Adobe plus Visio.  Ability to work with other publishing and scanning systems •  Exhibits good office etiquette, mutual respect and professionalism towards all.

In-House Counsel - Clinical Development and Medical Affairs
Fri, 11 May 2012 18:11:12 GMT

IN-HOUSE COUNSEL - CLINICAL DEVELOPMENT AND MEDICAL AFFAIRS JOB SUMMARY The In-House Counsel – CDMA provides a diverse range of legal services to the Clinical, Regulatory Affairs and Pharmaceutical Development functions within Aptalis, which operates in an inter-national and highly regulated environment. The In-House Counsel will prepare, review and assist in negotiating various types of agreements and other activities, potentially including review of draft scientific publications, regulatory documents, etc. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Draft and negotiate non-clinical agreements including laboratory services agreements, GMP service agreements and other research and development agreements. •  Draft and negotiate clinical agreements, CRO agreements, clinical service agreements, pharmacovigilence agreements, ICFs, authorizations and other clinical support documents. •  Draft and negotiate general contracts including confidentiality agreements, material transfer agreements, services agreements and consulting agreements. •  Review regulatory documents, and scientific materials, etc. •  Provide general legal counsel and support to clinical, medical affairs, regulatory, portfolio development and pharmaceutical development functional area. •  Identifies and helps elaborate plans to mitigate areas of legal risk affecting the business. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively with multiple ongoing projects and meets assigned deadlines. SUPERVISORY RESPONSIBILITY May be responsible for over-seeing paralegals or administrative assistants.  EDUCATION AND/OR EXPERIENCE JD from an accredited law school and a member in good standing of a US bar, plus three (3) or more years of direct R&D pharmaceutical experience with either a pharmaceutical company and/or law firm is required.  Experience with medical affairs, pharmacovigilance and/or regulatory documents is a plus.  QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Demonstrated sound business and legal judgment, with ability to balance business objectives and risk, solving legal problems in a high-output, fast moving environment. •  Excellent drafting and legal technical skills. •  Ability to prioritize duties and manage multiple matters from start to finish with minimal supervision. •  Exceptional attention to detail and excellent organizational skills. •  Excellent interpersonal, written and oral communication skills. •  Ability to work on complex problems with demonstrated creativity and problem solving skills. •  Ability to maintain the highest degree of confidentiality and integrity. •  Ability to respond effectively to sensitive inquiries or complaints. •  Ability to adapt to changes. •  Ability to coordinate, contribute to and work within a cross-functional/global team. •  Proficient in Microsoft Office. •  Ability to supervise and manage paralegals, if required.

Accounting Associate
Tue, 08 May 2012 14:06:56 GMT

ACCOUNTING ASSOCIATE JOB SUMMARY The Accounting Associate maintains the Company’s North American travel and expense reporting system, Concur. This position establishes new users, performs reconciliations, resolves issues and provides reporting on travel expenses. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Maintains the company’s Concur travel and expense reporting system for the three platforms: Aptalis Pharma US Inc, Aptalis Pharmatech Inc and Aptalis Pharma Canada, Inc. •  Reconciles travel expense and payment activities to the General Ledger on a weekly basis. •  Provides administrative support for processing and recording expense claims through the Concur travel and expense reporting system. •  Interacts and works with Concur on an ongoing basis to resolve any reporting issues that may occur with the system. •  Responsible for user set up and trouble shooting. •  Performs weekly expense report uploads from Concur to SAP and AX for all three platforms. •  Performs research when issues arise. •  Supports data requirements for state reporting and the Federal Sunshine Act compliance. •  Assists with monthly financial close, including preparation of assigned monthly general journal entries and account reconciliations. •  Understands and processes accounting transactions using SAP and AX software. •  Serves as back-up for Accounts Payable duties, using SAP software. •  Assists with special projects and/or assignments as required by the Company. •  Performs other duties as assigned. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY None EDUCATION AND/OR EXPERIENCE High school diploma with 5 – 10 years of accounting or bookkeeping experience required, associate’s or bachelor’s of science degree in accounting or business with a minimum of 2 years experience preferred. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Experienced with Accounting Software - SAP and/or AX preferred. •  Proficient in Microsoft Office including advanced skills in Excel (Pivot tables, Vlookup, Macros, If Statements, Formulas). •  Exceptional attention to detail and excellent organizational skills. •  Excellent interpersonal written and oral communication skills •  Ability to coordinate, contribute to and work within a cross-functional team. •  Ability to thrive in a dynamic and fast-paced environment. •  Able to prioritize duties and manage multiple projects from start to finish. •  Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.

Coordinator, Medical Affairs
Mon, 07 May 2012 13:38:15 GMT

COORDINATOR, MEDICAL AFFAIRS JOB SUMMARY The incumbent of this position is responsible for executing various administrative and specialized tasks for the Aptalis Medical Affairs department including grants coordination. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Schedules and plans meetings and events, arranges travel, organizes calendar, congress registration, prepares expense reports and provides general administrative support for the Vice-President of Medical Affairs and the Medical Affairs department. •  Organizes and documents decisions made by the Grants Committee for educational and research grants; prepares correspondence as applicable including responding to grantee requests. •  Maintains grant database and ensures appropriate tracking, processing, documentation and required outcomes takes place for all grants. •  Organizes monthly meetings of the Educational Grant (EG) and Investigator Initiated Studies (IIS) Committees, sends invitations, agendas and materials to designated participants, prepares and distributes minutes. •  Prepares letters of agreement (LOA), responds to invoices and ensures follow-up of all approved subsidies. •  Generally, represents the VP and Medical Affairs function as requested. •  Assists with the organization and implementation of advisory panel meetings and scientific conferences and comparable events led by the Medical Affairs department. •  Participates in the development and implementation of methods, procedures and policies necessary for the smooth operation and compliance of the department. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under deadlines. SUPERVISORY RESPONSIBILITY None EDUCATION AND EXPERIENCE High school diploma required; Associate Degree preferred. A minimum of three (3) to five (5) years’ experience as senior-level administrative assistant or coordinator. Experience in grant coordination or medical affairs in a Pharmaceutical organization is preferred. QUALIFICATIONS To perform this job successfully, an individual must be able to execute each essential task satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Excellent verbal and written communication skills with various stakeholders within and outside of company •  Discretion and maintenance of strict confidentiality •  Ability to work under pressure •  Good judgement skills with the ability to evaluate and prioritize •  Ability to respect tight deadlines and ensure appropriate follow-ups •  Attention to detail •  Ability to adapt and flex to a rapidly-changing environment •  Mastery of the Microsoft Office suite (advanced level) including Access. •  Perfect command of oral and written English •  Conversational French language proficiency would be an asset

Administrative Assistant, Legal
Fri, 04 May 2012 16:00:04 GMT

ADMINISTRATIVE ASSISTANT, LEGAL JOB SUMMARY The Administrative Assistant provides administrative and organizational assistance to the Legal  department. Duties include assistance with correspondence, meetings, events conference calls, invoicing and bill pay, docketing of legal matters, editing, archiving and management of legal documents, planning and organization, follow-up communications as required, and assistance with special projects.  Prepares and maintains legal documents and reports.  Maintains appoint-ments, court appearances, and other scheduling arrangements.  ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Provides administrative support in a variety of capacities including processing incoming mail, initiating telecommunications, filing, copying, faxing, and invoice/expense reporting. •  Files and maintains legal documents, corporate documents and litigation files in an organized manner that facilitates efficient retrieval. •  Works with Contract Administrator, as necessary, to maintain Contracts Database.  •  Maintains attorneys’ appointment schedules, greets guests, plans/arranges events and meet-ings as well as the registration to conferences.  •  Manages telephone calls from both internal and external sources.  Screens incoming calls and correspondence and responds independently when possible. •  Follows-up on pending matters, such as comments to be received, answers to be given, and answers or signatures to be received (letters, agreements, contracts, etc.). •  Organizes business trips and makes required traveling arrangements for the employees of the Legal department. •  Reviews invoices from outside firms to identify corresponding attorney and correct paying company subsidiary, and follows up with law firms as necessary, •  Works in SAP financial software to establish new vendors, and enter budget codes, contract data and legal invoices. •  Assists in scheduled conferences and meetings, writes the minutes of the meeting and en-sures follow-up on the discussed subjects. •  Prepares correspondence from draft stage to client-ready work and distributes as needed. •  Updates and maintains MS Outlook contacts. •  Acts as a liaison among Legal employees to facilitate work and accomplish objectives in a collaborative effort. •  Prepares expense reports. •  Maintains confidences and protects operations by keeping information confidential. •  Assists in preparing PowerPoint presentations and maintaining Excel spreadsheets. •  Performs special projects as assigned. •  Contributes to team effort by accomplishing related results as needed. •  Attends work on a regular and predictable basis. •  Serves as alternate back-up for front desk receptionist when necessary. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under deadlines. SUPERVISORY RESPONSIBILITY None. EDUCATION AND/OR EXPERIENCE High school diploma plus a minimum of five (5) years’ relevant experience is required. Expe-rience in a legal firm or internal legal department of an organization is preferred. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satis-factorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Must possess the highest level of work ethics and integrity with the ability to maintain confi-dentiality of information.  •  Possess strong administrative and organizational skills with the ability to take initiative to complete assignments and job responsibilities with minimal supervision. •  Ability to work in accounting software and processes legal invoices. •  Able to prioritize duties and contribute to multiple projects; including projects that are cross-functional and global. •  The individual must be able to effectively interface with a variety of people and work well under stressful situations. •  Must have excellent grammar and telephone etiquette and above average ability to interface with people using tact and diplomacy. •  Proficient in Microsoft Word, Excel and PowerPoint. •  Good working knowledge of office equipment is essential, such equipment including voice mail system, videoconference system, multi-line telephone and facsimile

Quality Control Manager
Fri, 04 May 2012 13:21:20 GMT

QUALITY CONTROL MANAGER This position is located in Vandalia, Ohio.   JOB SUMMARY: The basic job function is to manage and coordinate the functions of the Quality Control laboratory and its related activities.   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Manage the activities of the Quality Control (QC) laboratory to ensure timely, cost effective analytical efforts for Aptalis. •  Develop plans for the QC laboratory within all relevant Aptalis, GMP and FDA guidelines. •  Ensure compliance of the QC laboratory with all relevant, Aptalis, GMP and FDA guidelines, procedures and policies. •  Manage joint programs with vendors regarding raw material issues. •  Manage and develop QC laboratory personnel through coaching and mentoring in accordance with Aptalis philosophies, to include performance appraisals, training and development programs, team building, etc. •  Act as liaison for customer related quality or product queries. •  Identify resources required for effective and efficient operation of the QC laboratory. •  Recruit, train, and develop personnel to maximize their professional success and contributions to the company. •  Actively participate, with other managers, in the identification and resolution of problems related to Aptalis operations. •  Communicate and provide leadership to QC team members to foster positive attitudes, team effort, productivity, loyalty and quality improvements.  Communicate concerns, needs and recommendations to management. •  Review and approve documents as Quality Control representative. •  Maintain a safe working environment for QC laboratory personnel. •  Follow other job related instructions and perform other job related duties as requested.   GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY: Produces value-added results through effective recruitment, delegation, performance management, training and development of employees.     EDUCATION AND/OR EXPERIENCE: •  Bachelor’s or Master’s Degree in Analytical Chemistry or related field in science. •  Five plus years experience in analytical and laboratory operations, preferably in a Quality Control or Analytical Research and Development pharmaceutical environment. Three plus years of supervisory or management experience.   QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Interface with all internal departments, division and corporate management and outside agencies. •  Exhibit high degree of independence, receiving minimal supervision.  Ability to organize and prioritize work to meet deadlines. •  Strong oral and written communication skills, discretion and confidentiality required to interface with sensitive employee relations. •  Must be pro-active in anticipating needs of a dynamic business. •  Maintaining confidentiality of projects, test results, personnel matters and both customer and company information/data is a definite requirement. •  Proficient in advanced Microsoft Office. •  Thorough knowledge of method development, validation and method transfer principals.   PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope. 3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate la-boratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes. 6.  Working Conditions: The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes.   COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary QC Analytical Document Specialist
Fri, 04 May 2012 02:45:25 GMT

TEMPORARY QC ANALYTICAL DOCUMENT SPECIALIST JOB SUMMARY: Ensure QC compliance to GMPs by auditing laboratory documentation, reviewing test methods and SOPs for method accuracy and compliance to GMPs. Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”. ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Audit and approves laboratory documentation for QC and Raw Materials including data supporting release and stability testing for raw materials, intermediate products and finished products, method and process validations, method transfers and method verifications. •  Revise and update laboratory documentation and Standard Operating Procedures. •  Ensures all QC testing and documentation complies with cGMPs and the company’s internal quality standards •  Ensures laboratory personnel accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating Procedures. •  Perform investigations regarding customer complaints. •  Recognize and investigate Out of Specification results, Out of Trend results and deviations in accordance with cGMP guidelines •  Reviews any compendia (USP/NF, EP, BP, JP/JPE) changes and the impact to the company’s current raw material, intermediate and finished product testing and requirements •  Compile Annual Product Reviews. •  Shows a working knowledge of and the ability to evaluate results of HPLC, GC, UV, IR and wet chemistry techniques as applicable to a pharmaceutical lab environment •  Interfaces with Operations, Supply Chain, Technical Services, R&D and Regulatory Af-fairs. •  Work effectively under production and sales deadlines. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Other duties as required. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. SUPERVISORY RESPONSIBILITY: None. EDUCATION AND/OR EXPERIENCE: •  Masters degree or Bachelors degree in Analytical Chemistry or related scientific field with minimum of 4+ years experience in the pharmaceutical industry.   •  Knowledge of Pharmaceutical laboratory testing, analysis, documentation, cGMP and Regulatory requirements. •  Hands on experience required performing the following types of testing:  Dissolution, HPLC analysis, GC analysis, UV analysis, titrations. •  Experience in reviewing and auditing Laboratory documentation required. •  Prior supervisory experience a plus.   QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Excellent interpersonal skills. •  Ability to work with scientific and operations personnel. •  Strong technical writing skills, as well as organizational and project planning skills are required. •  Computer skills regarding use and application of Microsoft Excel and Word required, Microsoft Access a plus. •  Serve as technical resource for laboratory personnel. PHYSICAL REQUIREMENTS: 1. Physical Demands The employee is required to: •  drive vehicles, including but not limited to trucks under 26,000  GVW •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  exerts 10-20 pounds of force frequently, and/or •  exerts up to 100 pounds of force daily, •  moderate amounts of hammering when making and opening crates and boxes, •  occasionally uses ladders to climb into trucks for loading and unloading; also climbs stairs, •  temperature varies with outside weather conditions as incumbent is exposed to cold and heat when loading and unloading truck. •  able to lift up to 80 pounds. 2.Visual Ability Visual accommodation necessary for reading lists, documents, and driving vehicles. 3.License Required Valid Driver’s License 4.Hearing Ability Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken. 5.Working Conditions The employee is subject to: •  high noise levels from operating machines •  breathing exposure to dust, mists, and  fumes •  skin exposure to oils and chemicals COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance stan-dards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Associate Director of Manufacturing
Fri, 27 Apr 2012 12:18:53 GMT

ASSOCIATE DIRECTOR OF MANUFACTURING JOB SUMMARY: The position is responsible for production operations, as well as the engineering and maintenance of buildings and equipment. Aptalis is an Equal Opportunity Employer “EEO/M/F/D/V”. ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Manage operations, which include manufacturing, commercial and clinical packing, engineering and maintenance of buildings and equipment. •  Ensure, in collaboration with the Material Management Group, that production is in line with client expectations, quality standards and compliance, while enabling the organization to meet its sales and inventory targets. •  Ensure adequate management of engineering and maintenance of buildings and production equipment, identifies cost reduction or improvement opportunities on the overall effectiveness of operations and the level of compliance. •  Oversee operation improvement projects, “Lean manufacturing” initiatives, office expansion plans, and special projects in technological transfers or upgrades. You will actively take part in the economic justification of these various projects. •  Get involved in strategic or high-impact decisions related to building and infrastructure engineering and maintenance, equipment acquisition, as well as related service contract negotiations. •  Participate in the development and implementation of methods, procedures and regulations ensuring your team functions effectively, while respecting policies, procedures, rules and regulations prevalent in both the industry and the organization. •  Ensure full and consistent compliance with quality standards, quality procedures, Good Manufacturing Practices (GMP) and Environment, Health and Safety (EH&S) regulations. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. SUPERVISORY RESPONSIBILITY: Produces value-added results through effective recruitment, delegation, performance management, training and development of employees in the following positions EDUCATION AND/OR EXPERIENCE: •  Bachelor’s Degree in engineering or equivalent. •  A minimum of seven (7) years of experience in production and engineering, including a minimum of three (3) years in a management role, within the pharmaceutical industry or in a similar regulated environment. •  A Master’s Degree in Business Administration (M.B.A.) or Master’s Degree in Science (M.Sc.) in a relevant field (operations management, industrial engineering, project management, etc.) is considered an asset. QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Good knowledge of Good Manufacturing Procedures (GMP). •  Project management experience in large scale projects. •  Good knowledge of an ERP system, ideally SAP. •  Leadership skills. •  Ability to perform under pressure, establish priorities and meet tight deadlines. •  Managerial experience in a multidisciplinary context. •  Skills for written and spoken communications. •  Proficient in the use of the Microsoft Office software suite. •  Perfectly bilingual, French and English, both spoken and written. PHYSICAL REQUIREMENTS: 1. Physical Demands: The employee is required to: •  drive vehicles, including but not limited to trucks under 26,000  GVW •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  exerts 10-20 pounds of force frequently, and/or •  exerts up to 100 pounds of force daily, •  moderate amounts of hammering when making and opening crates and boxes, •  occasionally uses ladders to climb into trucks for loading and unloading; also climbs stairs, •  temperature varies with outside weather conditions as incumbent is exposed to cold and heat when loading and unloading truck. •  able to lift up to 80 pounds. 2.  Visual Ability: Visual accommodation necessary for reading lists, documents, and driving vehicles. 3.  License Required: Valid Driver’s License 4.  Hearing Ability: Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken. 5.  Working Conditions: The employee is subject to: •  high noise levels from operating machines •  breathing exposure to dust, mists, and  fumes •  skin exposure to oils and chemicals COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Analytical Group Leader
Fri, 27 Apr 2012 11:47:13 GMT

ANALYTICAL GROUP LEADER Position is located in Vandalia, OH. JOB SUMMARY: The essential job function is to communicate project goals to the teams, coordinate the tasks needed to meet the established project timelines assigned to the team, and mentor team members. Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  The Group Leader is responsible for the empowering of each member of the team to ensure the efficient operation of the group. •  The Group Leader reviews and approves relevant analytical documentation. •  The Group Leader writes and/or reviews technical reports, method transfers to and from QC and external laboratories, method development and project summaries, method validation protocols and reports, ANDA/NDA/DMF sections for inclusion in Regulatory filings and any other document necessary for the team. •  The Group Leader is responsible for assignment of necessary and appropriate personnel and resources to allow timely and effective method development and validation. •  The Group Leader performs necessary research of relevant literature. •  The Group Leader is responsible for reviewing, updating and approving relevant SOPs •  The Group Leader ensures that each member of the team is properly trained in the Aptalis Standard Operating Procedures (SOPs) needed for the tasks assigned to them.   . •  The Group Leader is responsible for facilitating the career development of the team members through training, mentoring, coaching, etc. •  The Group Leader ensures the team is compliant with all regulations as specified by OSHA, EPA, FDA or other Regulatory Agencies, and as defined in the Corporate Hygiene plan. •  The Group Leader is responsible for ensuring supplies and reagents needed to complete the project tasks are available. •  The Group Leader is responsible for the performance appraisals of members of the group. •  The Group Leader provides the necessary support, opportunity, and resources for members of the group to meet their performance objectives. •  The Group Leader is responsible for the smooth operation of the laboratory.  This includes ensuring all laboratory equipment is properly calibrated and functioning smoothly. •  The Group Leader communicates needs, issues, and updates to appropriate management and other personnel in a timely manner.  •  The Group Leader will interface with peers, supervisors, and subordinates in a professional manner. •  The Group Leader will perform other tasks as requested by the Management team.   GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY: Produces value-added results through effective recruitment, delegation, performance management, training and development of employees.   EDUCATION AND/OR EXPERIENCE: •  BS/BA in Chemistry or related field with a minimum of 10 years pharmaceutical experience •  MS/MA in Chemistry or related field with a minimum of 8 years pharmaceutical experience •  Or PhD in chemistry or related field with a minimum of 5 years pharmaceutical experience. •   Some formal or informal supervisory experience is preferred.   QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Proficient in HPLC analysis, key trouble shooter. •  Proficient understanding impurity analysis. •  Proficient in dissolution testing. •  Good understanding of GC •  Thermal Analysis or DSC •  Works independent of supervisor.  Incumbent conducts programs and research projects that are stated in terms of general objectives with limited supervision. •  Confidentiality of projects, tests results and both customer and Company information and data is required.   PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  Have the capability to work frequently on the computer •  Have the capability to travel by plane 2.  Visual Ability: Visual accommodation necessary for reading notebooks, lists,  documents and and operating laboratory equipment.. 3.  License Required: Valid Driver’s License 4.  Hearing Ability: Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken. 5.  Working Conditions: The employee is subject to: •  breathing exposure to dust, mists, and  fumes •  skin exposure to oils and chemicals   COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Staff Accountant
Thu, 26 Apr 2012 15:34:04 GMT

STAFF ACCOUNTANT JOB SUMMARY The Staff Accountant applies principles of accounting to compile information needed to close out the accounting information each month and assist in the preparation of financial reports while utilizing appropriate accounting control procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Compiles financial information to prepare entries to accounts, such as general ledger and subsidiary ledger accounts. •  Assists the Director, Accounting and Manager, Accounting in the analysis of certain accounts each month. •  Responsible for the reconciliation of various balance sheet accounts each month. •  Prepares and posts journal entries into the SAP system as needed. •  Assists, as needed, in the preparation of special accounting reports for management, the tax department or for regulatory authorities. •  Coordinates accounting matters with other departments and locations as needed. •  Assists in other tasks as requested. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under deadlines. SUPERVISORY RESPONSIBILITY This job has no supervisory responsibilities. EDUCATION AND/OR EXPERIENCE Bachelor’s degree in Accounting, and 1 to 2 years of accounting or bookkeeping experience required. Experience with SAP a plus.     QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Strong math aptitude, above average analytical skills and ability to work accurately with numbers and audit detail reports to ensure accuracy of monthly close. •  Excellent written and oral communication skills. •  Must possess strong administrative and organizational skills with the ability to take initiative to complete assignments and job responsibilities without supervision. •  Ability to prioritize responsibilities in order to meet stringent deadlines. •  Must possess a high proficiency in Microsoft Office, including Excel (Pivot tables, Vlookup, Formulas) and Word. •  Ability to coordinate, contribute to and work within a cross-functional team. •  Demonstrates an ability to clearly and accurately interpret and follow procedures and policies.

Staff Accountant
Tue, 24 Apr 2012 22:31:17 GMT

STAFF ACCOUNTANT JOB SUMMARY The Staff Accountant applies principles of accounting to compile information needed to close out the accounting information each month and assist in the preparation of financial reports while utilizing appropriate accounting control procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Compiles financial information to prepare entries to accounts, such as general ledger and subsidiary ledger accounts. •  Assists the Director, Accounting and Manager, Accounting in the analysis of certain accounts each month. •  Responsible for the reconciliation of various balance sheet accounts each month. •  Prepares and posts journal entries into the SAP system as needed. •  Assist in the accounting for revenue recognition of newly obtained products due to acquisitions. •  Reviews deposits and prepares them for posting in SAP. •  Reviews items posted to customers’ accounts related to chargebacks and returns and does the matching and clearing of these amounts from customers’ accounts. •  Assists, as needed, in the preparation of special accounting reports for management, the tax department or for regulatory authorities. •  Coordinates accounting matters with other departments and locations as needed. •  Assists in other tasks as requested. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under deadlines. SUPERVISORY RESPONSIBILITY This job has no supervisory responsibilities. EDUCATION AND/OR EXPERIENCE Bachelor’s degree in Accounting, and 1 to 2 years of accounting or bookkeeping experience required. Experience with SAP a plus.     QUALIFICATIONS   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Strong math aptitude, above average analytical skills and ability to work accurately with numbers and audit detail reports to ensure accuracy of monthly close. •  Excellent written and oral communication skills. •  Must possess strong administrative and organizational skills with the ability to take initiative to complete assignments and job responsibilities without supervision. •  Ability to prioritize responsibilities in order to meet stringent deadlines. •  Must possess a high proficiency in Microsoft Office, including Excel (Pivot tables, Vlookup, Formulas) and Word. •  Ability to coordinate, contribute to and work within a cross-functional team. •  Demonstrates an ability to clearly and accurately interpret and follow procedures and policies.

Senior Director, Medical Affairs - Global Medical Research
Mon, 23 Apr 2012 20:59:19 GMT

SENIOR DIRECTOR, MEDICAL AFFAIRS - GLOBAL MEDICAL RESEARCH JOB SUMMARY The Senior Director, Medical Affairs - Global Medical Research will be responsible for providing the strategic direction and tactical excellence for one or more assigned company’s brand life cycle management program.  This position will establish and communicate clear life cycle management product plans for all internal and external stakeholders, serving as the Clinical Lead for select Phase IIIb, Phase IV and investigator initiated studies, working effectively with the assigned brand/s, in a cross-functional manner, as one of the company’s clinical research experts.  ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Clinical Management •  Provides protocol and medical direction for all post-marketing, Ph IV and select IIIb clinical trials. •  Provides strategic direction and oversight for all investigator initiated studies. •  Provides scientific/medical support to brand/project planning, and the Life Cycle Management (LCM) team/s in collaboration with Marketing, other R&D functions, and Specialty Pharma Commercial team. •  Develops and executes the Publication Planning strategy. •  Manages the strategic alliance with Contract Research Organizations in collaboration with clinical operations. •  Participates in producing the medical components of INDs, NDAs, FDA and other regulatory communications. KOL Management •  Develops, maintains relationships with Key Thought Leaders to achieve Aptalis clinical objectives. •  Provides support to Key Thought Leaders in publishing and presenting scientific findings. •  Creates and manages ad hoc advisory boards for products. Other •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. SUPERVISORY RESPONSIBILITIES None EDUCATION AND/OR EXPERIENCE University diploma in Medicine (MD) with a minimum of seven (7) to ten (10) years of global pharmaceutical and/or biotech industry experience preferred with a strong expertise in life cycle management clinical  trial management. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Excellent written and oral communication skills. •  Ability to read, analyze, and interpret the most complex documents. •  Ability to respond effectively to the most sensitive inquiries or complaints. •  Ability to write speeches and articles using original or innovative techniques or style. •  Ability to define problems, collect data, establish facts, and draw valid conclusions. •  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. •  Ability to maintain the highest degree of confidentiality and integrity, represent the company’s high ethics, moral behavior, and professionalism. •  Quality planning and organization of work. •  A spirit of integration and analysis. •  Ability to work under pressure with the facility to adapt to a rapidly changing environment. •  Excellent command of the English language. •  Proficient in Microsoft Office.

Process Engineer
Thu, 12 Apr 2012 19:47:08 GMT

  Process Engineer           This position is located in Vandalia, Ohio.                                                      JOB SUMMARY: The essential job function is to assume responsibility for all process improvement activities associated with commercial production.  It includes monitoring of existing processes, identifying opportunities for improvement, and implementing both engineering and procedural improvements to further the continuous improvement efforts in the Manufacturing group.  It also includes support to ensure production schedules and requirements are satisfied, in addition to other daily functions needed or requested by the Manufacturing Manager.   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. • Evaluate existing processes for opportunities for improvement and perform cost/benefit analysis on each. Prioritize and implement based on evaluation. • Work with Manufacturing Manager to plan capital requirements during budget cycle each year. • Perform every aspect of capital project execution for Manufacturing from identifying needs and writing CARs, to ordering/installing equipment, to managing project budget. • Monitor QC data and set operating conditions based on analysis of data and validated limits. • Act as a technical training resource for Operators, Process Specialists, and Supervisors on OIMs, equipment upgrades, and process improvements. • Troubleshoot existing processes and equipment issues. • Support all Quality Systems for the Manufacturing Department, including CAPA, Change Control, DIR tracking/trending. • Support ERP efforts for Manufacturing. • Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidances and guidelines. • Support Manufacturing Department in developing and achieving departmental objectives that support the overall site goals, including working with Operators on Innovations to improve processes in the department. • Assist Technical Services Group with the execution of experimental and validation projects that use process equipment and facility. • Support Validation efforts for equipment, processes, and systems. • Involve operators in system/facility improvements. • Perform all these functions, and others, as required by the Manufacturing Manager in a professional and timely manner. • Evaluate and support R&D and Technical Services projects transitioning into manufacturing. • Evaluate and support product transfers from Aptalis manufacturing sites as well as outside purchased products. • Other duties as required. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY: None.   EDUCATION AND/OR EXPERIENCE: • 5-7 years experience in manufacturing operations, preferably in the pharmaceutical industry. • B.S. Degree in Engineering field or equivalent experience desired. • Knowledge and experience in Microencapsulation, Fluid Bed, and Finishing technologies highly desired.   QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  • High degree of oral and written communication skills to interface with other employees, cus-tomers and suppliers. • Must be capable of effectively communicating in both oral and written manner. • Must be able to provide accurate and affirmative instructions and reports to employees and management. • Must be able to organize, plan and control. • Must have job understanding sufficient to perform the duties listed above. • Must have good word processing and spreadsheet skills. • Knowledge of cGMPs compliance. • Interfaces with R&D, Manufacturing, Maintenance/Engineering, Logistics, Quality Control, Quality Assurance, Outside Vendors and Customers. • Incumbent exhibits high degree of independence, receiving minimal supervision. • Confidentiality required due to access to blueprints and written procedures regarding manu-facturing of products.  Also deals with confidential salary data.   COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Senior Manager, Regulatory Affairs, CMC
Thu, 12 Apr 2012 16:49:59 GMT

Senior Manager, Regulatory Affairs, CMC JOB SUMMARY: Senior Manager RA CMC is responsible for the definition and implementation of CMC regulatory support to any product/ project in any area of the Company’s business (Specialty Pharma, Inter-national Specialty Pharma, Pharmaceutical Technologies, and R&D). Such support is provided through the identification, implementation and management of the CMC regulatory development strategies, the preparation of CMC documents for the filings (e.g. IND, CTA, NDA, MAA, ANDA, and DMF), the interactions with regulatory authorities and the filing maintenance (e.g. amendments, supplements, and annual reports). This position provides primary on-site support to the Aptalis pharmaceutical technologies business and acts as liaison point for co-development partners and third party customers. Other responsibilities are linked to the GMP area, through the definition and implementation of activities to support the change control process and to support auditing related activities from US and ex-US regulatory authorities (e.g. EU authorities). ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Support Aptalis pharmaceutical technologies business : • This position provides primary on site support at the Vandalia facility to the Aptalis pharmaceutical technologies business and acts as liaison point for co-development partners and third-party customers. Contribute to submissions : • Responsible for Module 3 and 2.3 of assigned regulatory submissions and filing maintenance (CMC documents), including but not limited to IND, CTA, NDA, and MAA. • Assembles and maintains DMFs for third-party products • Ensures timely delivery of CMC documents by coordinating and soliciting components of the submission from various functional areas • Manages consultants/vendors for assigned projects • Manages the interaction with Clients and Regulatory Authorities (e.g. FDA, ex-us regulatory authorities) throughout development and registration • Manages the interaction with Regulatory and other departments colleagues from other locations throughout development and registration Regulatory representative in teams : • Represents CMC RA as a member of the Project Team for development and/or Life Cycle Management projects, implementing the regulatory strategy agreed with the Director Global RA CMC • Offers strategic and operational regulatory support to teams and interfacing functions in the company, including but not limited to manufacturing, quality assurance, project management, and marketing • Presents regulatory strategy and documents to relevant company committees as requested • Contributes to the department budget definition identifying the value of the activities related to the assigned projects Provides Regulatory intelligence : • Interprets applicable regulations and guidelines • Keeps project team abreast of regulatory decisions, issues, potential problems and new regulations to ensure that targeted claims are supported by the development program Other : • Maintains a high level of professional expertise through familiarity with scientific literature and participation in training courses • Attends work on a regular and predictable basis. • Completes assigned tasks in a safe manner and in a constant state of alertness. • Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. • Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: Bachelors Degree in Life Science, Pharmacy, or Medicine. Advanced Degree preferred. At least five (5) years of experience in regulatory activities in drug development in CMC aspects, and seven (7) years of experience in the pharmaceutical industry required. QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satis-factorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  • Excellent interpersonal written and oral communication skills • Proficient in Microsoft Office. • Ability to coordinate, contribute to and work within a cross-functional team. • Ability to thrive in a dynamic and fast-paced environment. • Ability to work independently since this position reports to Director CMC Regulatory Affairs in Pessano, Italy. • Able to prioritize duties and manage multiple projects from start to finish with minimal supervision. • Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision. • Exceptional attention to detail and excellent organizational skills. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Temporary Manufacturing QA Specialist I
Thu, 05 Apr 2012 17:58:13 GMT

TEMPORARY MANUFACTURING QA SPECIALIST I This position is located in Vandalia, OH. JOB SUMMARY: The primary responsibility of this position is auditing and approving of Batch Production documentation (Batch Production Records, SOPs, logs etc.), and ensuring adherence to cGMP’s.   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Audit and approve executed Batch Production Records. •  Review and approve Non-Conformance Investigations (Manufacturing, Calibration, SOP). •  Maintain and assure correctness of documentation. •  Interface with all departments within the company. •  Release Finished Product for shipment. •  Ensure facility adherence to cGMP’s and SOP’s. •  Maintain the confidentiality of pertinent information. •  Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management. •  Follow other job-related instructions and perform other tasks as required.   GENERAL REQUIREMENTS: •  This position requires a forty hour work week.  •  Position may require working overtime and weekend hours, as necessary. •  All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY: None.   EDUCATION AND/OR EXPERIENCE: •  Bachelor’s Degree preferred, with 0-2 years of Quality experience. •  Knowledge in cGMP’s as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment. •  Knowledge and/or working experience of large processing systems, fluid air systems, and/or coacervation system is highly preferred.   QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satis-factorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Accuracy and neatness of compiling documents are required. •  Good oral and written communication skills. •  Audits and approves Batch Production documentation •  Interfaces with all internal departments within the company •  Receives supervision as necessary •  Confidentiality of pertinent information is required   PHYSICAL REQUIREMENTS: •  The employee must be able to stand, walk, push, twist, reach overhead, and bend to the floor. •  The employee must have visual sharpness for reading written instructions and computer screen.   COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Temporary Quality Control Analyst
Wed, 04 Apr 2012 18:34:49 GMT

TEMPORARY QUALITY CONTROL ANALYST JOB SUMMARY The essential job function is to perform physical and chemical testing of intermediate and finished products according to written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  •Perform sampling of intermediate and finished products in accordance with cGMP guidelines. •Perform physical and chemical testing of intermediate and finished products as described in the documented procedures •Perform swabbing and analysis of clean equipment with moderate supervision. •Maintain laboratory equipment and work areas in good working condition. •Perform assigned calibrations for equipment in the laboratory. •Recognize and report Out of Specification results, out of trend results and deviations to supervisor. •Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating procedures. •Observes all safety procedures and regulations. •Other job-related tasks as required •Attends work on a regular and predictable basis. •Completes assigned tasks in a safe manner and in a constant state of alertness. •Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY None EDUCATION AND/OR EXPERIENCE •A Bachelor degree in Chemistry or related field •0 to 3 years experience in a Quality Control laboratory. •High degree of oral and written communication skills. •Experience with Microsoft Word, Excel and Access a plus   QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •Interfaces with R&D personnel, Manufacturing, Raw Materials, Supply Chain, Quality Control, and Quality Assurance. •Exhibits initiative and self motivation.  Can perform tasks, once trained, with limited supervision. •Confidentiality required due to access to written procedures regarding manufacturing and testing of products.  GENERAL REQUIREMENTS: This position requires good attendance, a standard eight-hour work day and five day work weeks.  Position may require working overtime, other shifts, weekend hours and possibly holidays. All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. PHYSICAL REQUIREMENTS: 1.Physical Demands: The employee is required to: •stand, walk, push, pull, twist, reach overhead, and bend to the floor •occasionally move items or equipment weighing up to 100 pounds •occasionally required to climb ladders and/or steps to reach equipment 2.Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory   instrumentation and equipment. 5.Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. COMPANY POSITION STATEMENT This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Quality Control Chemist
Wed, 04 Apr 2012 18:31:21 GMT

QUALITY CONTROL CHEMIST JOB SUMMARY: The essential job function is to perform physical and chemical testing of intermediate and finished products according to written procedures.  Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”. ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. • Perform sampling, physical testing, and chemical testing of intermediate and finished products as described in the documented procedure with minimal supervision in accordance with cGMP guidelines. • Perform swabbing and analysis of clean equipment with minimal supervision in accordance with cGMP guidelines. • Maintain laboratory equipment and work areas in good working condition. • Perform assigned calibrations and preventative maintenance for equipment in the laboratory.  • Recognize and troubleshoot equipment issues. • Recognize and investigate Out of Specification results, Out of Trend results and deviations in accordance with cGMP guidelines and report results to supervisor. • Audit laboratory documentation. • Assist with training of QC Analysts and temporary personnel. • Responsible for laboratory systems as assigned (i.e. logbooks, calibrations, standards) • Revise and update laboratory test methods and Standard Operating Procedures. • Accurately maintain notebooks and files compliant with current GMPs and internal Standard Operating procedures. • Observes all safety procedures and regulations. • Other job-related tasks as required GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. SUPERVISORY RESPONSIBILITY: Produces value-added results through effective recruitment, delegation, performance management, training and development of employees. EDUCATION AND/OR EXPERIENCE: • A Bachelor degree in Chemistry or related field • 3 to 7 years experience working in a Quality Control or Research and Development Laboratory, preferably in the pharmaceutical industry. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  • Working knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices. • Working knowledge of current Good Manufacturing Practices (GMPs) • Proficient in Microsoft Excel, Word.  Microsoft Access experience a plus • Basic knowledge of technical writing coupled with good oral communication skills. PHYSICAL REQUIREMENTS: 1. Physical Demands: The employee is required to: • stand, walk, push, pull, twist, reach overhead, and bend to the floor • occasionally move items or equipment weighing up to 100 pounds • occasionally required to climb ladders and/or steps to reach equipment 2. Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5. Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6. Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes.   Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed.   Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: • Interfaces with R&D personnel, Manufacturing, Raw Materials, Supply Chain, Quality Control, Quality Assurance, and outside vendors. • Exhibits high degree of independence, receiving minimal supervision. • Exhibits a high degree of oral and written communication skills. • Confidentiality required due to access to written procedures regarding testing and manu-facturing of products.  COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Senior Director, Medical Affairs - Global Medical Communications
Mon, 02 Apr 2012 22:06:52 GMT

SENIOR DIRECTOR, MEDICAL AFFAIRS - GLOBAL MEDICAL COMMUNICATIONS JOB SUMMARY The Senior Director, Medical Affairs - Global Medical Communications is responsible for providing medical and scientific expertise and oversees all portfolio activities related to Global Medical Information, Medical Communication and Continuing Medical Education; develops and leads the field based medical group; building and maintaining relationships with Key Thought Leaders to increase the organization’s visibility as an industry leader. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Medical content and communication •  Provides medical content and communication for the Aptalis portfolio of marketed products with deep experience in medical communication and life cycle management. •  Provides scientific/medical support to brand/project planning, and the Life Cycle Management (LCM) team in collaboration with Marketing, other R&D functions, and Specialty Pharma Commercial Operations. •  Oversees the dissemination of scientific and medical information related to marketed products.  •  Participates in producing the medical components of INDs, NDAs, FDA and other regulatory communications. •  Oversees production and revision of AMCP dossiers and supports Managed Care with medical content and presentation to formularies. •  Develops the strategic plan and provide oversight for medical grants and congresses.  •  Oversees and manages library services and respective contractors. •  Supports product promotional campaigns to ensure scientific/medical validity, including appropriate messaging of product benefit and warnings. •  Will develop the education / communication outreach needed for marketed and launch products including advisory boards and speaker programs. •  Manages Continuing Medical Education programs to ensure educational programs that are accredited and of high quality and consistent with regulatory compliance requirements. •  Will lead across the portfolio the company’s call center(s) and internal stakeholders’ education for compliance and a seamless execution. Will oversee the development and/or enhancement of medical SOPs for the medical affairs function. •  Supports development and execution of response letters and FAQs. Other •  Hires, assigns, develops and supervises employees under his supervision.  •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. SUPERVISORY RESPONSIBILITIES Produces value-added results through effective recruitment, delegation, performance management, training and development of employees in the following positions: •  Medical Science Liaison/s •  Senior Manager, Medical Affairs Operations EDUCATION AND/OR EXPERIENCE University diploma in Medicine (MD) with a minimum of seven (7) to ten (10) years pharmaceutical or biotech industry experience in medical communications across a global portfolio of products.  QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Excellent written and oral communication skills. •  Ability to read, analyze, and interpret the most complex documents. •  Ability to respond effectively to the most sensitive inquiries or complaints. •  Ability to write speeches and articles using original or innovative techniques or style. •  Ability to define problems, collect data, establish facts, and draw valid conclusions. •  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. •  Ability to maintain the highest degree of confidentiality and integrity, represent the company’s high ethics, moral behavior, and professionalism. •  Quality planning and organization of work. •  A spirit of integration and analysis. •  Ability to work under pressure with the facility to adapt to a rapidly changing environment. •  Excellent command of the English language. •  Proficient in Microsoft Office.

Temporary Batch Operator (6)
Fri, 02 Mar 2012 21:00:07 GMT

TEMPORARY BATCH OPERATOR This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Temporary Batch Operator (5)
Fri, 02 Mar 2012 20:59:41 GMT

TEMPORARY BATCH OPERATOR This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Temporary Batch Operator (4)
Fri, 02 Mar 2012 20:59:22 GMT

TEMPORARY BATCH OPERATOR This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Temporary Batch Operator (3)
Fri, 02 Mar 2012 20:58:14 GMT

TEMPORARY BATCH OPERATOR This position is located in Vandalia, OH. EEO/M/F/DV JOB SUMMARY: This is an entry level position at Aptalis and the skills learned during training will enable the new operator to perform essential job functions.  The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures.  ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Learning to disassemble, clean and reassemble production equipment to prepare for processing. •  Learning to conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meets specified consistency as outlined in written procedures. •  Learning to operate the process equipment to create product that meets pre-determined specifications. •  Learning to monitor and record critical process parameters.  Learning to make necessary adjustments to assure finished product meets customer specifications. •  Learning to transfer processed materials through production equipment to include dryers, filtration systems, blenders, and sieving equipment. •  Learning to package finished product and transfer to warehouse. •  Learning to operate solvent recovery system to assure cyclohexane ingredient is of the purest form. •  Follows all documentation procedures assuring that paperwork is in accordance with all company and regulatory standards. •  Responsible for keeping work area neat and orderly along with observing all safety procedures. •  Follows other job-related instructions and performs other job-related duties as requested. •  Adheres to cGMP guidelines as well as the CFR. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: • High School diploma or equivalency. • 1+ years experience in manufacturing environment. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Ability to perform mathematical calculations. •  1 + years experience in manufacturing environment. •  Must be able to read and understand written instructions. •  Proficient speaker of English language. PHYSICAL REQUIREMENTS: 1.  Physical Demands: The employee is required to: •  stand, walk, push, pull, twist, reach overhead, and bend to the floor •  occasionally move items or equipment weighing up to 100 pounds •  occasionally required to climb ladders and/or steps to reach equipment 2.  Visual Ability: Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.  3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms and detect machine sounds and malfunctioning equipment to identify and diagnose changes in order to take appropriate action. 6.  Working Conditions:  The employee may be required to wear personal protective equipment during certain phases of the operation; the employee is subject to high noise levels from operating machinery; skin exposure to oils, vapors, and a variety of chemicals (required to wear gloves when working with hazardous materials); breathing exposure to dust, mists, and fumes. Any employee whose position requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personnel protective equipment.  Employee is required to wear such approved personal protective equipment whenever thus exposed. Engineering controls are in place to minimize or eliminate exposure to these conditions wherever practical.  Aptalis complies with all applicable OSHA, and EPA, standards for environmental safety and health. SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED: •  Interfaces with R&D, manufacturing, maintenance, shipping/receiving, and quality control personnel. •  Receives direct supervision and works mainly with a trainer or higher level operator. •  Confidentiality required due to access to blueprints and written procedures regarding mixing and blending of raw materials. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

Senior Analytical Chemist
Wed, 29 Feb 2012 15:12:01 GMT

SENIOR ANALYTICAL CHEMIST   This position is located in Vandalia, Ohio.   JOB SUMMARY: The essential job function is to oversee development and validation of analytical methods for raw materials, work-in-process, and finished products.  Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”. ESSENTIAL DUTIES AND RESPONSIBILITIES: The essential job function is to oversee development and validation of analytical methods for raw materials, work-in-process, and finished products.  MAJOR RESPONSIBILITIES: •  Develop and validate analytical methods, utilizing appropriate instrumentation (e.g. HPLC, dissolution, GC). •  Collect and compile necessary literature to support the development process; utilizing all necessary information available from publications such as USP, NF, BP, JEP, Florey, etc. •  Record all work and data in the approved laboratory notebooks. •  Comply with all regulations as specified by OSHA, EPA, FDA, etc., and as defined in Corporate Hygiene plan. •  Prepare and/or revise technical reports and other documents. •  Ensure all necessary equipment, supplies and reagents are ordered in advance of need. •  Assist in transferring analytical procedures to Quality Control. •  Train other analytical chemists and technicians. •  Stay abreast of government regulations and assure that other chemists are trained and informed on all aspects of regulations. •  Maintain laboratory equipment and perform analytical troubleshooting and minor repairs on lab equipment. •  Follow and perform other job-related duties as requested. GENERAL REQUIREMENTS: The position requires good attendance, a standard eight-hour day, and five-day work week.  The employee must be fluent in written and spoken English.  Position may require working overtime and weekends. All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. SUPERVISORY RESPONSIBILITY: None. EDUCATION AND/OR EXPERIENCE: •  MS in Analytical Chemistry or equivalent degree in physical sciences with a minimum of 5 years or PhD with minimum of two years of relevant laboratory experience, BS with a minimum of 8 years.  QUALIFICATIONS:   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  In-depth knowledge of Pharmaceutical operations, including lab procedures and equipment, instrumentation, safety procedures, and laboratory practices; mathematical analysis and statistical computations; government regulations.  •  Working knowledge of personal computers and legible handwriting. •  Interface with internal and external customers and vendors. •  Ability to work independently. PHYSICAL REQUIREMENTS: 1.  The employee is required to: •  Stand, walk, push, twist, reach overhead, and bend to the floor. •  Frequently move items up to 50 pounds and occasionally required to move items or objects up to 100 pounds. •  Occasionally required to climb ladders and/or steps to reach equipment. 2.  Visual Ability: Visual accommodation necessary for reading precision measuring equipment, machine dials, gauges, and thermometers; must be able to observe fine details under microscope; must be able to distinguish color indicator changes in test solution. 3.  Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4.  Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5.  Hearing Ability: Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken. 6.  Working Conditions: The employee is subject to: •  High noise levels from operating machinery •  Skin exposure to oils, vapors, and a variety of chemicals.  (Required to wear gloves when working with hazardous materials.) •  Breathing exposure to dust, mists, and fumes The employee may be required to wear a respirator and must pass the required respirator evaluation test. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).  

VP Global Quality Assurance
Wed, 29 Feb 2012 15:07:15 GMT

VICE PRESIDENT, GLOBAL QUALITY ASSURANCE - VANDALIA JOB SUMMARY Responsible for organizing, managing and controlling all quality assurance and quality compliance activities and tasks for the Company and its subsidiaries while respecting the established regulatory requirements and policies of the Company. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Directs global quality assurance functions for all manufacturing and clinical related activities of the company. •  Defines globally-coordinated quality assurance and compliance objectives, quality assurance systems, agreements, training programs, and policies for all Company and subsidiaries and develops the necessary plans and actions to meet established objectives. •  Ensures continuing compliance with relevant Company, local law and regulatory authority requirements. •  Establishes and manages global and local operational budgets to reach established objectives. •  Organizes and manages quality assurance team to meet requirements and objectives of the function. •  Evaluates site audit findings and responds to these findings with globally-aligned process and procedure improvements that drive quality system efficiency and effectiveness. •  Provides quality assurance expertise to all operating groups and establishes and participates in cross-functional teams as required. •  Provides support and assistance to Regulatory and Medical Affairs in preparation of regulatory submissions and reviews. •  Provides support to answering Regulatory (FDA, TPD, EMEA, etc.) questions/comments during filing review in their quality assurance function.  •  Participates actively in maintaining relationships with regulatory authorities (FDA, TPD, etc.). •  Ensures appropriate risk assessment with regards to projects/available resources. •  Provides support to internal and external Company initiatives as required, including participation in due diligence processes, R&D development programs, and third-party sourcing. •  Manages human resources and provides coaching to the quality assurance team. •  Acts as the company’s representative by showing respect for the established values of the Com-pany. •  Participates in the development and implementation of processes  methods, procedures and regulations necessary for the smooth operation of the department. •  Respects policies, procedures and regulations in force in the company. •  Global coordination of site quality department operations and continuous improvement of quality systems for maximized effectiveness and resource utilization on a global basis. •  Participation in the development of the Annual Operating Plan. •  Responsible for monitoring customer satisfaction at the product quality and quality system levels and reports this satisfaction status to management. •  Responsible for assigning and managing the performance of Management Representatives, Authorized Persons, and other key quality system / regulatory compliance positions. •  Evaluates the global drug and devices development processes and makes recommendations to R&D management on process improvements. GENERAL REQUIREMENTS All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. SUPERVISORY RESPONSIBILITIES Global Quality Assurance function with teams based in the U.S, Canada, France and Italy  EDUCATION AND/OR EXPERIENCE Bachelor of Science, (MS or PhD preferred) or related degree, with at least fifteen (15) years of progressive management experience in quality assurance within the pharmaceutical industry that includes multi-site and/or global scope. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Extensive knowledge of Canadian, American and European good manufacturing practices (GMP). •  Extensive knowledge of global GLP and Clinical QA •  Operational knowledge of pharmaceutical dosage form manufacturing techniques and processes and quality controls •  Operational knowledge of pharmaceutical product development and clinical study processes. •  Operational knowledge of quality assurance and compliance techniques and procedures. •  Operational knowledge of Canadian, American and European regulations. •  Proficiency in implementing quality management procedures, standards, programs and concepts in a global scope. •  Technical and scientific expertise sufficient to direct day-to-day group activities. •  Experience in cross-functional team and project management. •  Ability to develop and implement quality management tools. •  Ability to recognize people skills and a proven track record in personnel development. •  Ability to organize and manage the work of department employees. •  Excellent written and oral communication skills with the Company’s various internal and external stakeholders. •  A spirit of integration and analysis. •  Ability to work under pressure. •  Quality of judgment and evaluation of situations. •  Business sense. •  Ability to adapt to a rapidly changing environment.

R&D Formulations Group Leader
Wed, 29 Feb 2012 15:02:19 GMT

FORMULATIONS GROUP LEADER   JOB SUMMARY: The position is responsible for proposing, screening, evaluating and implementing product and technology development projects.   It is also the responsibility of this position to lead, direct, and prioritize projects assigned to this position and associated Formulation staff.   Aptalis is an Equal Opportunity Employer “EEO/M/F/DV”.   ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Lead in the development of new drug delivery technologies and products. •  Keep current with regulations and technical knowledge.  •  Secure and provide adequate scientific formulation support to all assigned projects. •  Interface with internal and external clients in project meetings. •  Assist Business Development in preparation of R&D project proposals.  Provide input on the technical feasibility and resources required of the project. •  Provide cost and man-hour estimates associated with R&D project proposals. •  Direct priorities for within the position. •  Provide input on project planning. •  Ensure all activities comply with OSHA, EPA, DEA and cGMP's regulations. •  Maintain detailed records of all work to ensure compliance of all product submissions to the requirements by government agencies. •  Prepare and review CMC text for NDA/ANDA/DMF and other regulatory filings. •  Prepare and review master batch records, development pharmaceutics reports and other formulation documents. •  Provide necessary training and mentoring to junior Formulation staff. •  Participate in the interview and hiring of quality individuals to fill needed roles. •  Perform other tasks as requested by the Senior Director of Pharmaceutical Development.   GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination.   SUPERVISORY RESPONSIBILITY: Produces value-added results through effective recruitment, delegation, performance management, training and development of employees.   EDUCATION AND/OR EXPERIENCE: •  Minimum of a PhD Degree in Pharmaceutical Sciences or a related field with 6-10 years experience in the pharmaceutical industry.    •  Solid background in pharmaceutics, biopharmaceutics or processing technologies in order to be able to invent, innovate and implement new ideas.  •  Broad knowledge and extensive experience in drug product development projects in various phases to facilitate efficient and successful implementation of projects.   •  Experience and training in supervision.    QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Hired, supervised and trained professional employees. •  Excellent interpersonal skills. •  Knowledge and application of regulations relating to supervising employees. •  Ability to work with scientific and operations personnel of customers and affiliates. •  Computer literate. •  Assist in the preparation and timely submission of ANDAs/NDAs, SOPs and other government filings. •  Presentation skills to technical personnel. •  Serve as technical resource.   PHYSICAL REQUIRMENTS: 1. The employee is required to: •  Stand, walk, push, twist, reach overhead, and bend to the floor, •  Frequently move items up to 50 pounds and occasionally required to move items or objects up to 100 pounds, •  Occasionally required to climb ladders and/or steps to reach equipment. 2. Visual Ability: Visual accommodation necessary for reading precision measuring equipment, machine dials, gauges, and thermometers; must be able to observe fine details under microscope; must be able to distinguish color indicator changes in test solution. 3. Smelling Ability: Must have sense of smell to detect odors of unacceptable compounds and/or mixtures. 4. Manual Dexterity: Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment. 5. Hearing Ability: Must be able to hear alarms, detect machine sounds and malfunctioning equipment to identify and diagnose changes so appropriate action can be taken. 6. Working Conditions: The employee is subject to: •  High noise levels from operating machinery. •  Skin exposure to oils, vapors, and a variety of chemicals.  (Required to wear gloves when working with hazardous materials.) •  Breathing exposure to dust, mists, and fumes.   COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments).

Vice President, Human Resources - North America
Wed, 22 Feb 2012 21:27:51 GMT

VICE PRESIDENT, HUMAN RESOURCES – NORTH AMERICA   JOB SUMMARY The Vice President, Human Resources - North America leads, and directs the Company’s human resource initiatives and activities for North America. Formulates and drives “best practice” HR activities, policies and procedures to ensure expert HR collaboration and value-added services are being delivered across the US and Canada. Additionally, this position acts as a consultant to management regarding human resource opportunities and strategic HR planning.   ESSENTIAL DUTIES AND RESPONSIBILITIES • Serves as strategic business partner by translating corporate objectives into North American HR strategy to achieve organizational goals. • Engages key stakeholders in driving the organization’s articulated goals, values, vision and culture while encouraging entrepreneurial, aggressive and prudent risk-oriented business activities. • Champions a human resources culture that is proactive and anticipatory, viewed by its internal clients at all levels to be absolutely expert, leading edge, confident, thorough, strategic, effective and vital to the organization’s success.  • Partners with global HR team to develop and implement programs to attract, retain and motivate high-quality talent at all levels to achieve growth objectives and strategies.  • Collaborates with senior management and senior staff to advise, develop, and execute plans and activities. Interacts regularly with other department heads, directors, and key staff to respond to and provide appropriate services.  • Plays an active leadership role in supporting global initiatives effectively across a highly matrixed organization.  • Adapts and promotes best-in-class practices, fosters collaboration across countries / sites, ensures smooth implementation of HR solutions and builds the overall capability of the North American organization. • Directs the application and interpretation of HR policies throughout the organization to ensure economy and efficiency of work processes. Ensures that sound HR policies and practices are in place in US and Canadian field locations.  • Collaborates with senior management and HR team to drive workforce planning initiatives in North America. • Oversees employee recruitment, hiring, and on-boarding. • Partners with Total Rewards team to ensure the effectiveness of performance driven compensation, rewards, and benefits strategies to attract, retain, and reward staff while achieving internal and external equity.  • Ensures compliance with U.S. and Canadian regulations. • Provides critical and timely advice and counsel in sensitive, controversial, and precedent-setting situations. • Directs, develops and oversees the structure and organization of HR staff to ensure effective fulfillment of short and long-term objectives.  • Achieves financial objectives by forecasting requirements, developing a budget, and managing expenditures within budget.Monitors, analyzes, and evaluates regularly and systematically the performance of HR against budget objectives and related goals. Oversees reporting and appraisal of results. • Works with senior HR team to design and implement change management initiatives. • Attends work on a regular and predictable basis. • Completes assigned tasks in a safe manner and in a constant state of alertness. • Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. • Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. • Takes initiative to get along with others. SUPERVISORY RESPONSIBILITY Leads a team of 10 HR professionals with 4 direct reports. Produces value-added results through effective recruitment, delegation, performance management, training and development of employees in the following positions: • Director, Human Resources – Canada • Director, Human Resources - Vandalia • Senior Manager, Talent Acquisition – US • Manager, Human Resources - US EDUCATION AND/OR EXPERIENCE Master’s degree from a four-year college or university, plus a minimum of 15 years of progressive human resources management experience, with at least 5 years in a senior management role.   QUALIFICATIONS          To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Expertise in planning, developing, implementing and leading “best practice” and operational human resources strategies within a global, highly matrixed environment. • Experience integrating a workforce that is geographically dispersed and possess outstanding cross-cultural relationship building and communication skills. • Extensive knowledge of talent management, organizational effectiveness, employee relations, compensation, benefits, staffing, HRIS and compliance, including affirmative action, US and Canadian employment laws and regulations. • Must be a motivating, collaborative, results-oriented leader with several years experience managing teams and the political savvy to influence senior-level executives.  • Strong background in effecting positive change to enhance and develop leadership within the organization and promote employee productivity and retention. • Must possess an organized, self-directed approach with a strong track record of following through on commitments and managing multiple expectations simultaneously. • Strong management, organizational and problem-solving skills with particular emphasis on ability to quickly provide advice and counsel to all levels of staff, and direct successful resolution of sensitive, controversial, or precedent-setting issues. • Possess excellent communication skills, both oral and written, with the ability to present ideas in a compelling way; and communicate with tact and diplomacy when dealing with employees on confidential matters. • Visionary, energetic, innovative and entrepreneurial with proven analytical skills and business acumen. • Must possess strong emotional IQ and the ability to lead under pressure within a fast paced, ever-changing environment. • Must have a solid understanding of budgeting and metrics. • Proficient in Microsoft Office. • Ability to accommodate 25% travel.    

Project Manager, Project Management
Fri, 17 Feb 2012 15:11:52 GMT

PROJECT MANAGER, PROJECT MANAGEMENT JOB SUMMARY The incumbent is primarily responsible to support and optimize product development advancement through project planning, multidisciplinary team coordination, process facilitation and communication. ESSENTIAL DUTIES AND RESPONSIBILITIES • Responsible to support and manage the product development advancement of Aptalis’ Specialty Pharma projects from early development through launch and beyond via optimal project planning, forming and coordinating global cross-functional project teams, facilitating key under-lying processes as well as serving as the single-point communication conduit for the team. • In collaboration with the teams and the team leader, builds and maintains the multi-disciplinary project plan. Identifies, communicates and monitors the critical path of the project. • In partnership with the project team leader, drives execution of chosen strategy per agreed plan with the Team with a view to manage the overall project to time, quality, budget, scope and risks. • Coordinates preparation of regular cross-functional project team meetings as well as ad hoc functional sub-groups meetings as requested (scheduling, agenda preparation, material preparation). Chairs project team meetings involving all key stakeholders, maintains and distributes timely meeting minutes as well as actions, decisions, issues and communication logs. • Seeks timely progress for actions and resolution to issues. Follows-up on critical action items and alerts all needed of potential roadblocks or delays. • In collaboration with the team leader and Project Management Head, escalates critical, high impact items per established processes with a view to assist the team in obtaining timely decisions or clarifications from management as needed. • Prepares monthly project status reports and other project updates or reviews needed by the organization. Reports project progress according to project milestones. • Assists the different Clinical & Regulatory Affairs functions in the preparation of their annual project budget and their LBEs/YTG forecasts. Provides project information to Finance to assist in long term planning as required. • Exhibits proficiency in working with the different Project Management tools, processes, procedures and databases that are both established as well as to be newly created, consolidated or harmonized. Some examples include Platform, XRM, TIMAX, FTE-planner tool, and the like. • Attends work on a regular and predictable basis. • Completes assigned tasks in a safe manner and in a constant state of alertness. • Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. • Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. SUPERVISORY RESPONSIBILITIES None EDUCATION AND/OR EXPERIENCE • Advanced degree (such as Masters) in Pharmaceutical Sciences or a related field required. A minimum of 6 years of experience in the pharmaceutical industry in either Clinical Research, Regulatory Affairs or Pharmaceutical Development areas including previous active participation in a multidisciplinary team of product development. Direct experience in Project Management as well as a certification in Project Management constitutes an asset. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Adequate knowledge of the drug development and registration process in the US with a working knowledge of global requirements. • Manage multiple projects, objectives and often competitive and changing deadlines with a proven track record of organizational, interpersonal, prioritization and multi-tasking skills. • Exceptional English language skills, both written and oral that enables quality communications with various stakeholders, both inside as well as outside the Company. • Stimulate, motivate and build effective inter-personal work relationships across all disciplines. • Ability to influence and lead without direct authority. • Commitment to goals with a positive “can do” approach to solving problems; team-player. • Excellent organizational skills; highly process-oriented. • Exhibits sound judgment, analytical acumen and concern for detail under pressure. • Respects and understands tight schedules and ensures follow-ups as essential. • Ability to maintain confidentiality, discretion, tact and diplomacy in all aspects of work. • Strong customer service orientation. • Ability to work under direction with a fair bit of autonomy. • Proficient in project management tools and techniques that include, but are not limited to, Gantt charts, project/work break-down structures, SMART goal-setting, obstacles and conflict management, delegation, risk analysis and mitigation, etc. • Computer-savvy with an excellent knowledge of Microsoft Office including Microsoft Project.

VP, Global Licensing, Pharmaceutical Technologies
Mon, 21 Nov 2011 22:30:02 GMT

 VP, GLOBAL LICENSING, PHARMACEUTICAL TECHNOLOGIES   JOB SUMMARY: Responsible for creating and implementing an effective, proactive growth strategy for Aptalis’s Pharmaceutical Technology licensing business. The VP, Global Licensing, Pharmaceutical Technologies will lead a team that identifies and evaluates new opportunities and structures relationships with pharmaceutical companies globally, maximizing the values of Aptalis’s technologies and related products. ESSENTIAL DUTIES AND RESPONSIBILITIES: The primary duties and responsibilities of this position include the following.  Other duties may be assigned. • Develops and implements a global licensing strategy for the company’s pharmaceutical technologies and associated products portfolio. • Identifies and generates new business opportunities for the Pharmaceutical Technology business unit. • Develops and implements tactical plans targeted to the achievement of financial and product approval objectives. • Actively participates as a senior member of the Pharmaceutical Technology leadership team in defining business unit goals and objectives and the development of an Annual Business Plan. • Negotiates development, licensing and supply agreements with third parties. • Collaborates with the R&D function in the creation and maintenance of a balanced co-development product pipeline portfolio. • Collaborates with the R&D team in the development and acquisition of pharmaceutical technologies. • Collaborates across the organization with teams that include, scientists, physicians and regulatory, legal, finance and manufacturing professionals. • Positions Aptalis Pharmaceutical Technologies as a leading pharmaceutical technology company in the marketplace. • Actively participates in the promotion of the company globally, including participation in leading industry conferences. • Establishes and manages global and local operational budgets to reach established objectives. • Organizes and manages an international licensing team to meet requirements and objectives of the function. • Manages human resources and provides coaching to the licensing team. • Acts as the company’s representative by showing respect for the established values of the Company. • Participates in the development and implementation of processes, methods and procedures regulations necessary for the smooth operation of the department. • Respects policies, procedures and regulations in force in the company. GENERAL REQUIREMENTS: All employees are required to comply with the organization’s Privacy Policy.  Failure to abide by these requirements may result in the employee’s immediate termination. SUPERVISORY RESPONSIBILITIES: Lead a team that identifies and evaluates new opportunities and structures relationships with pharmaceutical companies globally, maximizing the values of Aptalis's technologies and related products. EDUCATION AND/OR EXPERIENCE: Bachelor of Science, (MS or PhD preferred) or related degree, with at least ten (10) years of experience and record of accomplishment in business development activities in the pharmaceutical industry, preferably with experience in drug delivery or pharmaceutical development technologies.   QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Extensive knowledge of the international pharmaceutical industry, companies and products. • Extensive knowledge of technology and product licensing practices. • Operational knowledge of product development pathways, international regulatory systems, intellectual property and pharmaceutical manufacturing practices. • Ability to work with an internationally based team in multiple locations. Experience in cross-functional team and project management. • Ability to recognize people skills and a proven track record in personnel development. • Ability to organize and manage the work of department employees. • Excellent written and oral communication skills with the Company’s various internal and external stakeholders. • A spirit of integration and analysis. • Ability to work under pressure. • Quality of judgment and evaluation of situations. • Business sense. • Ability to adapt to a rapidly changing environment. COMPANY POSITION STATEMENT: This is not necessarily an exhaustive list of all responsibilities, duties, performance standards or requirements, efforts, skills or work conditions associated with this position.  While this is intended to be an accurate reflection of the current job, Aptalis reserves the right to revise the job or to require that other or different tasks be performed when circumstances change (e.g. emergencies, change in workload or technology developments). Travel Requirements Global travel required. Total travel estimate: 40% - 50% of time.

Manager, Compensation
Wed, 02 Nov 2011 13:35:40 GMT

MANAGER, COMPENSATION JOB SUMMARY Manages global compensation function for the Company through the planning, developing and implementing new and revised compensation programs, policies, procedures that are internally equitable, externally competitive and that are responsive to the corporate goals. Assures thorough audits, reports and personal contact that company compensation programs are consistently administered in compliance with policies and government regulations. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Global Compensation •  Monitors the effectiveness of existing compensation policies, guidelines and procedures recommending plan revision as well as new plans which are cost effective and consistent with compensation trends and corporate objectives; coordinates implementation and provides guidance to management. •  Develops recommendations to adjust global salary structure in response to changing organi-zational needs and market values. •  Develops implements and administers incentive plans globally for different employee groups as required. •  Prepares reports and incentive review files and incentive payments, ensuring adherence to budget. •  Provides monitors and analyzes benchmark data, trend information and economic projections to ensure the Company’s compensation strategy maintains competitive market position. •  Works with global HR teams to standardize compensation processes and ensure consistency within global and local structures. •  Designs and implements special compensation programs or incentive systems to support the organization's objectives. •  Contributes to global Total Rewards and other HR projects (i.e., Total Reward Statements benefit programs, performance calibration, etc). •  Provides complex analysis and modeling for compensation and benefits projects and pro-grams. •  Serves as consultant to managers regarding compensation issues. •  Leads the global annual salary increase process. •  Prepares presentation and other communication materials related to compensation and benefits •  Assists Vice President, Total Rewards and HR Operations with various analyses, modeling and ad-hoc reporting as needed. Other •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code •  Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public. •  Takes initiative to get along with others. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Works effectively under deadlines. SUPERVISORY RESPONSIBILITY None EDUCATION AND/OR EXPERIENCE BS/BA degree from a four-year accredited university or college; plus a minimum of 5 years re-lated experience required. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satis-factorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  •  Attention to detail with strong analytical and problem-solving skills. •  Knowledge in compensation plan methodologies and design characteristics, survey analysis procedures and/or data collection techniques are required. •  Prior experience designing and administering pharmaceutical sales incentive plans is pre-ferred. •  Strong project management skills and the ability to translate complex data for a variety of audiences. •  Proficiency in Microsoft Office, expert in Excel. Comfortable with large complex spreadsheet design and analysis. •  Experience working in a high-performance work environment within a multi-national organiza-tion. •  Ability to define problems, collect data, establish facts, and draw valid conclusions. •  Ability to maintain the highest degree of confidentiality and integrity, and represent the Com-pany’s high ethics, moral behavior, and professionalism.  

Senior Vice President and General Counsel
Wed, 28 Sep 2011 13:58:44 GMT

SENIOR VICE PRESIDENT AND GENERAL COUNSEL JOB SUMMARY The Senior Vice President and General Counsel is responsible for directing and overseeing legal matters pertaining to the Company including but not limited to the following areas: intellectual property (“IP”), general corporate, compliance, stock and transactional/contract matters. This position provides assistance to the Management Team on all legal matters; and in identifying, evaluating and negotiating new business opportunities for the Company including obtaining financing. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Directs and manages the activities of the legal group. •  Provides Management with guidance in identifying critical legal problems and counsels them on policy, corporate structure, corporate governance and strategy issues. •  Advises Company concerning transactions of business involving internal affairs, directors, officers, and corporate relations with general public. •  Works with the Management Team to identify, evaluate and negotiate new product and business acquisitions.  •  Assists with developing new market opportunities and expanding the distribution of current products through strategic alliances. •  Provides legal expertise in the development, acquisition and licensing efforts of new products. •  Advises Management on intellectual property law including patents. •  Participates in banker interactions regarding funding and financing. •  Supervises corporate stock matters including private investments in the Company, initiating an IPO, stock-based compensation and compliance with regulations. •  Oversees development and implementation of policies and procedures to ensure compliance with laws, rules and regulations that are applicable or relevant to the products and services the Company provides, and the markets in which we operate. •  Utilizes legal principals to identify opportunities for minimizing risks and maximizing profits. •  Develops budget recommendations to support systematically planned programs of legal actions or defenses, and establishes controls to assure optimum deployment of resources within approved budgets. •  Prepares business contracts and/or initiates changes in standard form contracts. •  Serves as Corporate Secretary. •  Keeps fully informed of new developments in corporate legal matters and keeps all levels of management informed of applicable new laws and of the progress and results of court cases. •  Develops a professionally competent staff of business-oriented legal specialists. •  Interprets laws, rulings, and regulations for the Company. •  Acts as agent of corporation in litigation and other legal proceedings. •  Administers other legal matters as required by the Company. •  As required, supplements in-house legal work by carefully selecting outside legal assistance and monitors and evaluates their activities. •  Responsible for all other legal matters as requested by CEO and/or Board of Directors. •  Attends work on a regular and predictable basis. •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY Directly supervises the following positions: •  In-house Attorneys •  Paralegals EDUCATION AND/OR EXPERIENCE Juris Doctorate degree required plus actively licensed to practice law in New Jersey. Additionally, 20 years related experience and/or training is required; life sciences or pharmaceutical experience a plus. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. •  Experience and thorough knowledge of IP, licensing, corporate, employment and business law. •  Ability to manage a significant number of projects simultaneously and to thrive in a dynamic and fast-paced environment •  Global legal experience including business development mergers and acquisitions, corporate compliance, corporate structure, employment issues, tax and clinical development agreements •  Experience working with the financial community on funding and financing; and experience with corporate stock (private and public), IPOs and SEC regulations. •  Excellent written and oral communication skills •  Proven analytical capacity, superior financial and business judgment. •  Must have high interpersonal skills to handle a variety of situations; position continually requires demonstrated poise, tact and diplomacy. •  Must be detail oriented. •  Excellent organization and time management skills. •  Ability to work effectively and supportively within a global team.  

In - House Counsel
Sun, 28 Aug 2011 19:38:51 GMT

JOB SUMMARY The In-House Counsel will provide guidance and legal advice to the Business Development functional area of the business within Aptalis Pharma, which operates in an international and highly regulated environment. Key responsibilities include drafting, negotiating and reviewing a variety of contracts and business related documents; providing due diligence support for business development activities, assisting with corporate (SEC related) filings, and managing litigation. ESSENTIAL DUTIES AND RESPONSIBILITIES • Provides general business law, regulatory and corporate compliance related advice in support of identified divisions and departments. • Drafts, reviews and concludes contracts and other business related documents in support of business activities. • Provides due diligence support for business development activities. • Remains current on laws, rulings and regulations affecting business or within identified areas of responsibility and recommends appropriate action. • Identifies and recommends plans to mitigate areas of legal risk affecting the business. • Manages the preparation, review and filing of compliance related records and reports. • Manages outside counsel, including in litigation and other regulatory proceedings, as required. • Attends work on a regular and predictable basis. • Completes assigned tasks in a safe manner and in a constant state of alertness. • Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. • Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. • Works effectively under deadlines. SUPERVISORY RESPONSIBILITY May supervise Paralegal or Legal Assistant EDUCATION AND/OR EXPERIENCE Member in good standing of the US bar with a minimum of ten (10) years of practice experience working in a corporate legal environment or a major law firm. A minimum of three (3) years of direct pharmaceutical industry experience in business development transactions is preferred. Experience in the areas of corporate compliance, general commercial and contract law, are all relevant; and knowledge in product liability, and intellectual property a plus. QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Sound business/legal judgment with ability to balance business objectives and risk, solving legal problems in a high-output, fast moving environment. • Excellent drafting and legal technical skills. • Possess ability to function independently and have the ability to be proactive in delivering support and advice. • Ability to maintain the highest degree of confidentiality and integrity. • Able to prioritize duties and manage multiple matters from start to finish with minimal supervision. • Exceptional attention to detail and excellent organizational skills. • Strong interpersonal, written and oral communication skills. • Ability to work on complex problems with demonstrated creativity and problem solving skills. • Ability to respond effectively to sensitive inquires or complaints. • Self-directed organizational abilities and proven attention to detail. • Ability to coordinate, contribute to and work within a cross-functional team.