About Aptalis

Employment Opportunities in Canada

Project Management Officer (ITS)
Fri, 17 Feb 2012 21:19:49 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

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.    

Manager, Regulatory and Labeling Operations
Wed, 22 Feb 2012 17:18:32 GMT

MANAGER, REGULATORY AND LABELING OPERATIONS JOB SUMMARY The Regulatory and Labeling Operations Manager manages activities associated with the sub-mission of Regulatory documentation to the FDA.  This includes identifying and sourcing submission content and managing and working closely with Regulatory Management on coordination of submission timelines. This position is responsible for working with other Regulatory staff and authors to prepare electronic dossiers for the purpose of electronic or paper submissions, using the corporate software standard.  This position acts as an internal expert for the Electronic Document Management System/Software (EDMS) and will be responsible for educating those authors, reviewers and approvers in the use of the EDMS as well ensuring that the dossiers are built to acceptable Regulatory Standards. In addition, this position is responsible for operational aspects of the Aptalis product labeling review, approval and archiving processes. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Manages the operational component of submission production, process maintenance and oversees the publishing of submissions including establishing an operations timeline, formatting, editing, reviewing, publishing, production (paper and electronic), and archiving (paper and electronic). •  Manages all technical aspects for submissions and status updates to concerned parties. •  Provides leadership to the teams to ensure submissions are in accordance with electronic specifications and/or standard industry practices. •  Uses technical expertise to become lead for eCTD (electronic common technical document) submissions. •  Maintains expert knowledge of internal and external publishing standards; ensures all as-pects of Company e-submissions meet regulatory agency and Aptalis technical standards and requirements •  Serves as EDMS administrator (‘super user’) for Clinical and Regulatory Affairs business unit. •  Manages and maintains Aptalis/FDA electronic submissions gateway. •  Develops best practices for Regulatory Affairs and collaborates with other departments to establish practices based on the functional area business processes. •  Performs electronic publishing tasks including assembling submissions electronically with final output on paper and/or electronic media. •  Creates Hyperlinks/Cross-References/Bookmarks in the regulatory submission documents to allow FDA reviewers to navigate around the submission. •  Troubleshoots document issues. •  Collaborates with regulatory and line function personnel for planning, preparation, publishing, and quality control checks of submissions •  Works closely with outside vendors to accomplish submission goals as appropriate. Labeling Operations •  Maintains the Aptalis official labeling repository. •  Places approved product labeling on internal/external websites. •  Coordinates SPL (structured product labeling) submission to FDA. General •  Completes assigned tasks in a safe manner and in a constant state of alertness. •  Works in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Upholds Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Attends work on a regular and predictable basis. SUPERVISORY RESPONSIBILITY None EDUCATION AND/OR EXPERIENCE •  Bachelor’s degree or higher from a four-year accredited university or college in a relevant technical (information management or computer science) or scientific field, or equiva-lent/relevant work experience; plus •  5 years’ experience in electronic document management, publishing (eCTD), and regulatory submissions management gained within the pharmaceutical industry or CRO sector. •  Insight Manager and Publisher experience preferred (or equivalent). •  SharePoint experience preferred (or equivalent). •  Experience and understanding of eCTD structure 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.  •  Expert knowledge/experience with evaluation, implementation, and validation of relevant in-dustry software and hardware. •  Basic understanding of pharmaceutical regulatory submission requirements (FDA/EMA). •  Excellent interpersonal written and oral communication skills. •  Proficient in Microsoft Office including advanced skills in Excel (Pivot tables, Vlookup, Ma-cros, If Statements, Formulas). •  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. •  Exceptional attention to detail and excellent organizational skills.  

Contract Corporate Recruiter
Wed, 22 Feb 2012 13:58:18 GMT

Contract Recruiter Aptalis is a privately held, leading specialty pharmaceutical company providing  innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders.  We have manufacturing and commercial operations in the U. S., the European Union and Canada.  Our vision is to become the reference specialty pharma company providing innovative, effective therapies for unmet medical needs, including cystic fibrosis and gastrointestinal disorders, and we hope to achieve this through our mission:  to improve health and quality of care by providing specialty therapies for patients around the world.  We will strive to improve patient quality of care thanks to a broad range of products in cystic fibrosis and gastrointestinal disorders, a robust pipeline, technology platform, manufacturing capabilities and a skilled team of professionals with deep understanding of our customers’ needs. In addition to our marketing activities, we also formulate and clinically develop enhanced pharmaceutical and biopharmaceutical products for ourselves and others using our proprietary pharmaceutical technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet formulations. Due to our ongoing high growth, we are seeking a contract recruiter for an estimated 2 month assignment that may be extended longer term.  Compensation is based on experience.  To be successful in this position, you will bring your proven track record to:  1. identify and attract top talent for all levels of positions through various resources including leads, referrals, search engines, and networking 2.  interact on a professional basis with hiring managers 3.  review resumes, pre-qualify candidates via phone screens and schedule interviews 4.  manage and communicate with candidates on a weekly basis throughout the talent acquisition process 5.  manage multiple open opportunities simultaneously and with efficiency 6.  input daily activity updates into applicant tracking system (Taleo) 7.  interact in collaboration with Human Resources team   

Specialist, Study Management
Mon, 20 Feb 2012 19:14:49 GMT

SPECIALIST, STUDY MANAGEMENT JOB SUMMARY The Specialist, Study Management directly assists the Clinical Study Manager in coordinating all activities related to the clinical trials assigned, mainly phase I to IV studies.   ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Manages the ‘’Trial Master File’’ (TMF) follow-up and evaluation utilizing clinical study man-agement systems (CTMS) in collaboration with partners (CROs) selected for each trial. When possible, makes monitoring visits to the CROs during trials to ensure a regular control regarding the updating of these documents. •  Ensures the proper implementation and maintenance of follow-up tools for selected patients (e.g., IVRS) related to the availability and the investigational drug assignment plan. •  Assists the CRO in monitoring investigational drugs, from their selection-labeling-packaging-stocking and distribution to research sites to their final reconciliation. •  Follows up on activities related to clinical trials using the CTMS at the disposal of the CRO and for extracting reports that can be used to preserve historical data on each clinical trial. •  Ensures coordination of Clinical Operations deliverables and works in close collaboration with the Clinical Study Manager on the general management of clinical studies under his/her responsibility, from implementation to conclusion. •  Reviews all changes made to consent forms used by each clinical research centre as re-ported by the CRO. •  Requests the translation of documents associated with clinical studies and follows up with partners; reviews the translations and makes sure of their correspondence to the original documents. •  Participates in the set up of presentation materials used at investigator meetings. •  If needed, collaborates with the Head of Clinical Trials Management for a specific trial regarding the necessary cooperation between internal and external regulatory departments. •  Responds to logistical comments made during inspection procedures and works with CRO to provide appropriate corrective measures. •  Participates in the regular production of newsletters in collaboration with the Study Manager and the CRO. •  Obtains from the CRO the required documents pertaining to the trials and their conclusion and organizes their storage according to established norms. •  May supervise the operations linked to all logistical aspects of studies initiated by researchers and phase I studies. •  Participates in the review of Clinical Operations SOPs. •  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 in life sciences (biology, bioche-mistry, etc.); plus at least 2 years experience in clinical research or specialized graduate diploma (D.E.S.S.) in drug development 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 with various stakeholders within and outside the Company; effectively utilizes tact and diplomacy. •  Exceptional attention to detail and excellent organizational skills. •  Ability to accurately review documents. •  Understands the clinical process of drug development. •  Possesses excellent knowledge of Good Clinical Practices (GCP) and rules. •  Possesses strong ethics and the ability to work in a highly regulated environment (GCP, HPB, etc.). •  Demonstrates good judgment and ability to evaluate situations correctly. •  Able to prioritize duties and manage multiple projects from start to finish respecting tight deadlines and ensuring follow-up. •  Ability to thrive in a dynamic and fast-paced environment. •  Proficient in Microsoft Office. •  Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.

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.

Temporary Associate Chemist
Wed, 15 Feb 2012 14:02:18 GMT

TEMPORARY ASSOCIATE CHEMIST EEO/M/F/D/V This position is located in our Vandalia, OH office. JOB FUNCTION: The essential job function is to perform physical and chemical laboratory testing of raw materials, work-in-process, and finished products.     MAJOR RESPONSIBILITIES: With little supervision, the analyst is required to : 1. Provide support for method development activities 2. Provide support for method validation activities 3. Investigate deviations With no supervision, the analyst is required to : 4. Perform sampling and testing of feasibility and GMP batches 5. Maintain accurate documentation and maintain appropriate GMP compliance 6. Maintain lab equipment 7. Follow other job-related instructions and perform other job-related tasks as required.   Additionally, the analyst must follow all required safety procedures.   KNOWLEDGE AND EXPERIENCE : • BS in Chemistry or equivalent degree in physical sciences with four to eight years of relevant laboratory experience or… • MS in chemistry or other physical sciences with one to six years of relevant laboratory experience. • Detailed knowledge of HPLC, GC, KF moisture analysis, particle size equipment, dissolution apparatus, and related laboratory equipment. • Working knowledge of personal computers and legible handwriting.   GENERAL REQUIREMENTS : The position requires good attendance, a standard eight-hour day, and five-day work week.  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.   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.   SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED : • Interface with R&D personnel, manufacturing, quality control, and outside vendors. • The position receives minimal supervision.   Confidentiality of projects, test results, and both customer and Company information/data is required. 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).  

Associate Chemist
Tue, 14 Feb 2012 15:43:02 GMT

ASSOCIATE CHEMIST EEO/M/F/D/V This position is located in our Vandalia, OH office. JOB FUNCTION: The essential job function is to perform physical and chemical laboratory testing of raw materials, work-in-process, and finished products.     MAJOR RESPONSIBILITIES: With little supervision, the analyst is required to : 1. Provide support for method development activities 2. Provide support for method validation activities 3. Investigate deviations With no supervision, the analyst is required to : 4. Perform sampling and testing of feasibility and GMP batches 5. Maintain accurate documentation and maintain appropriate GMP compliance 6. Maintain lab equipment 7. Follow other job-related instructions and perform other job-related tasks as required.   Additionally, the analyst must follow all required safety procedures.   KNOWLEDGE AND EXPERIENCE : • BS in Chemistry or equivalent degree in physical sciences with four to eight years of relevant laboratory experience or… • MS in chemistry or other physical sciences with one to six years of relevant laboratory experience. • Detailed knowledge of HPLC, GC, KF moisture analysis, particle size equipment, dissolution apparatus, and related laboratory equipment. • Working knowledge of personal computers and legible handwriting.   GENERAL REQUIREMENTS : Overnight Travel % is less than 10%. The position requires good attendance, a standard eight-hour day, and five-day work week.  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.   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.   SCOPE OF CONTACTS, DEGREE OF CONTROL, AND DEGREE OF INTERPERSONAL SKILLS REQUIRED : • Interface with R&D personnel, manufacturing, quality control, and outside vendors. • The position receives minimal supervision.   Confidentiality of projects, test results, and both customer and Company information/data is required. 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
Tue, 14 Feb 2012 14:58:03 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).  

Temporary Warehouse Operator
Thu, 09 Feb 2012 21:23:46 GMT

TEMPORARY WAREHOUSE OPERATOR     EEO/M/F/DV BASIC FUNCTION: The essential job function is to provide proper warehouse management assistance in handling materials, work-in-process, finished products and other miscellaneous items.  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. •  Prepares finished product for shipment to customer to include pulling and matching outgoing orders, inspecting and labeling finished drums, recording seal numbers, and preparing shipping documents. •  Receive raw materials to include unloading drums, categorizing and verifying materials, inspecting, following hazardous materials procedures, and entering receipts into Fourth Shift. •  Completes appropriate paperwork for QC to release and transport raw materials in warehouse. •  Takes inventory of raw materials and finished products as requested. Maintains inventory of shipping materials and supplies. •  Responsible for sampling and labeling of raw materials being received and as requested. •  Operates lift truck to move, convey, or hoist shipments from shipping/receiving platform to storage or work area. Responsible for maintenance of lift truck. •  Prepares, handles and labels various hazardous and non-hazardous waste materials for disposal. •  Maintains proper warehouse orderliness, cleanliness and safety. •  Receives packages from small freight carriers (UPS, Federal Express, etc.).  Inspects receipts and delivers items to proper individuals.  Packages and ships item for UPS, Federal Express, etc. •  Follows other job-related instructions and performs other job related tasks 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. •  Work effectively under production and sales deadlines. SUPERVISORY RESPONSIBILITY: None EDUCATION AND/OR EXPERIENCE: •  High school diploma or equivalency. •  6-12 months material handling experience. 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. 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 Employee whose vocation requires exposure to these conditions receives training in Hazardous Communication Standards and use of mandatory personal 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.  Eurand complies with all applicable OSHA and EPA standards for environmental, safety and health. 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.  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).      

Process Engineer
Thu, 09 Feb 2012 21:20:55 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).

R&D Formulations Group Leader
Thu, 09 Feb 2012 21:19:17 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).

Director, Quality
Thu, 09 Feb 2012 21:16:05 GMT

DIRECTOR, QUALITY  JOB SUMMARY: The essential job function is to assure Aptalis and its vendors comply with all FDA regulation and guidance documents. Provide direction, leadership and development to the Quality Assurance/Control and Operations staff. Develop, maintain and continuously improve the Quality System to assure conformance with all cGMP’s and regulatory requirements. 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. 1.  Assure cGMP and regulatory compliance with all FDA and applicable external US regulatory requirements and guidance documents within Aptails and its vendors. 2.  Direct and assure all Aptalis Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies. 3.  Direct and manage all FDA and other regulatory agency activities including inspections, inquiries, notifications, all and other agency associated activities. 4.  Manage Aptalis’s audit program to include internal audits and vendor audits. 5.  Manage and direct a vendor certification program. 6.  Set and maintain appropriate policies and procedures to maintain regulatory compliance. 7.  Coordinate customer and regulatory audits of Aptalis (Operations Group). 8.  Develop quality systems for use at Aptalis to ensure production of quality product and all of its related activities (e.g. Engineering, QC). 9.  Develop cGMP and other relevant Quality System training programs for Aptalis employees. 10. Approve all documentation used in relation to production of product and its related activities (validation, quality, control testing, engineering, etc.). 11. Lead and provide guidance to the compliance team. 12. Direct and manage the following specific activities:       • Problem investigation systems (including “out of specifications”)       • Annual product reviews       • Customer complaints       • Change control program       • SOP, Batch Record System       • Specifications       • Provision of quality and production data for drug master files       • Quality Manual preparation       • Product release (intermediate and finished)       • All regulatory documents and controls  13. Lead the personnel in accordance with Aptalis philosophies to include performance appraisals, training and development programs, team building, etc. 14. Identify resources required for effective and efficient operation of the department. 15. Recruit qualified and able personnel, as required, for the department. 16. Actively participate in the management of Aptalis and the development and implementation of policies. 17. Actively participate, with other managers, in the identification and resolution of problems related to Aptalis operation. 18. Communicate and provide leadership to staff to obtain good attitude, team effort, productivity, loyalty and quality improvements. Communicate concerns, needs and recommendations to management. 19. Provide and assist Regulatory with ANDA, NDA or IND applications as needed. 20. Follow other job-related instructions and perform other job-related tasks 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 in the following positions: Quality Assurance Manager and Quality Control Manager. EDUCATION AND/OR EXPERIENCE: B.S./M.S. in Chemistry or other Physical Sciences fields with 5-15 years of industrial leadership experience, with minimum 10 years of Quality experience. QUALIFICATIONS  To perform this job successfully, an individual must be able to perform each essential duty satisactorily. 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 Manufacturing, R&D, Management personnel, customers, outside vendors, suppliers, consultants and government agencies.       • Work with minimal supervision; review problems, issues or questions with supervisor.       • Confidentiality of projects, test results, and both customer and Company information/data is a definite requirement. Thorough knowledge of:       • cGMP, GLP and DEA regulations       • NDA and ANDA requirements       • Personal computers       • Technical report writing along with good oral communication skills       • Audit procedures PHYSICAL REQUIREMENTS: 1. Physical Demands: The employee is required to:       • Stand, walk, push, pull, twist, reach overhead, and bend to the floor;       • Frequently moves 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, gages, and thermometers; must be able to observe fine details under microscope; must be able to distinguish color indicator changes in test solutions. 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. 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. 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).

Pharmaceutical Sales Specialist
Wed, 08 Feb 2012 21:45:40 GMT

SALES SPECIALIST - DENVER 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 outside sales 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.

In-House Counsel - Clinical Development and Medical Affairs
Tue, 07 Feb 2012 20:19:39 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.

Regional Sales Manager - Northeast Region
Mon, 23 Jan 2012 19:25:54 GMT

REGIONAL SALES MANAGER - NORTHEAST REGION JOB SUMMARY The primary responsibility of the Regional Sales Manager (RSM) is to successfully implement sales and marketing plans, achieve or exceed sales goals for volume and profitability, and manage field sales representatives and expenses in an assigned region. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Leading the regional sales effort to achieve or exceed sales goals. •  Recommending sales department appointments, promotions, etc. for the assigned region. •  Monitoring and controlling regional sales departmental budgets. •  Implementing the training and development of field sales personnel. •  Participating in meetings to contribute to overall Company operations, field sales salary review process and the development of marketing plans. •  Conducting semi-annual business reviews with sales representatives. •  Interacting with office staff on behalf of field sales personnel to ensure proper communications and appropriate cooperation. •  Be knowledgeable of competitive products, techniques, and activities. •  Maintain a neat and professional appearance at all business functions. •  Complete assigned tasks in a safe manner and in a constant state of alertness. •  Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Work in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Take initiative to get along with others. SUPERVISORY RESPONSIBILITY Supervises field sales representatives as assigned. EDUCATION AND/OR EXPERIENCE Bachelor’s degree from four-year accredited college or university, Master’s degree preferred. A minimum of four years pharmaceutical sales experience required, management 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. •  The ability to attract, hire and retain top performers. •  Proven ability and willingness to lead and work effectively with others in order to achieve organizational goals •  Ability to remain focused on priorities, goals, and objectives •  Proven ability to influence others and maintain the image and behavior of a leader •  Ability to accommodate extensive travel. •  Possess a valid driver’s license in the state of residence.  Also, must possess and maintain a driving record that is acceptable to the Company. •  Proficient in Microsoft Word, Excel and PowerPoint. PHYSICIAL DEMANDS •  While performing the duties of this job, the employee is required to travel by air and automobile. •  The employee must occasionally lift and/or move up to 60 pounds.

Regional Sales Manager - Mountain Region
Mon, 23 Jan 2012 19:21:54 GMT

REGIONAL SALES MANAGER - MOUNTAIN REGION JOB SUMMARY The primary responsibility of the Regional Sales Manager (RSM) is to successfully implement sales and marketing plans, achieve or exceed sales goals for volume and profitability, and manage field sales representatives and expenses in an assigned region. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Leading the regional sales effort to achieve or exceed sales goals. •  Recommending sales department appointments, promotions, etc. for the assigned region. •  Monitoring and controlling regional sales departmental budgets. •  Implementing the training and development of field sales personnel. •  Participating in meetings to contribute to overall Company operations, field sales salary review process and the development of marketing plans. •  Conducting semi-annual business reviews with sales representatives. •  Interacting with office staff on behalf of field sales personnel to ensure proper communications and appropriate cooperation. •  Be knowledgeable of competitive products, techniques, and activities. •  Maintain a neat and professional appearance at all business functions. •  Complete assigned tasks in a safe manner and in a constant state of alertness. •  Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Work in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Take initiative to get along with others. SUPERVISORY RESPONSIBILITY Supervises field sales representatives as assigned. EDUCATION AND/OR EXPERIENCE Bachelor’s degree from four-year accredited college or university, Master’s degree preferred. A minimum of four years pharmaceutical sales experience required, management 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. •  The ability to attract, hire and retain top performers. •  Proven ability and willingness to lead and work effectively with others in order to achieve organizational goals •  Ability to remain focused on priorities, goals, and objectives •  Proven ability to influence others and maintain the image and behavior of a leader •  Ability to accommodate extensive travel. •  Possess a valid driver’s license in the state of residence.  Also, must possess and maintain a driving record that is acceptable to the Company. •  Proficient in Microsoft Word, Excel and PowerPoint. PHYSICIAL DEMANDS •  While performing the duties of this job, the employee is required to travel by air and automobile. •  The employee must occasionally lift and/or move up to 60 pounds.

Regional Sales Manager-Three Rivers Region
Mon, 23 Jan 2012 19:19:10 GMT

REGIONAL SALES MANAGER - THREE RIVERS REGION  JOB SUMMARY The primary responsibility of the Regional Sales Manager (RSM) is to successfully implement sales and marketing plans, achieve or exceed sales goals for volume and profitability, and manage field sales representatives and expenses in an assigned region. ESSENTIAL DUTIES AND RESPONSIBILITIES •  Leading the regional sales effort to achieve or exceed sales goals. •  Recommending sales department appointments, promotions, etc. for the assigned region. •  Monitoring and controlling regional sales departmental budgets. •  Implementing the training and development of field sales personnel. •  Participating in meetings to contribute to overall Company operations, field sales salary review process and the development of marketing plans. •  Conducting semi-annual business reviews with sales representatives. •  Interacting with office staff on behalf of field sales personnel to ensure proper communications and appropriate cooperation. •  Be knowledgeable of competitive products, techniques, and activities. •  Maintain a neat and professional appearance at all business functions. •  Complete assigned tasks in a safe manner and in a constant state of alertness. •  Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. •  Work in a cooperative manner with managers, supervisors, coworkers, customers and the public. •  Take initiative to get along with others. SUPERVISORY RESPONSIBILITY Supervises field sales representatives as assigned. EDUCATION AND/OR EXPERIENCE Bachelor’s degree from four-year accredited college or university, Master’s degree preferred. A minimum of four years pharmaceutical sales experience required, management 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. •  The ability to attract, hire and retain top performers. •  Proven ability and willingness to lead and work effectively with others in order to achieve organizational goals •  Ability to remain focused on priorities, goals, and objectives •  Proven ability to influence others and maintain the image and behavior of a leader •  Ability to accommodate extensive travel. •  Possess a valid driver’s license in the state of residence.  Also, must possess and maintain a driving record that is acceptable to the Company. •  Proficient in Microsoft Word, Excel and PowerPoint. PHYSICIAL DEMANDS •  While performing the duties of this job, the employee is required to travel by air and automobile. •  The employee must occasionally lift and/or move up to 60 pounds.  

VP Global Quality Assurance
Mon, 23 Jan 2012 18:36:44 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.

Senior Coordinator, R&D Payments
Tue, 17 Jan 2012 21:08:49 GMT

SENIOR COORDINATOR, R&D PAYMENTS JOB SUMMARY The incumbent is primarily responsible to coordinate the issue of purchase requisitions and over-see the approval of vendor invoice payments per established processes and systems  in partnership with Project and Resource Management for all the functions under the Chief Medical Officer (CMO) globally (namely Clinical Development & Operations, Medical Affairs & Pharmacovigilance, Regulatory Affairs, and Pipeline Strategies.) ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Creates Purchase Requisitions or equivalent for all global R&D-CMO functions (related to both specific projects as well as other unassigned cost centers) in a timely manner subse-quent to receipt of executed vendor contracts from Legal, per current Finance practices, processes and systems in place that may include SAP and/or Microsoft AX. •  Procures and processes vendor invoice payment approvals per contractual and technical terms for all global R&D-CMO functions in order to ensure that approvals and payments are timely, accurate, and compliant with contractual and technical obligations. •  Ensures that entered requisitions capture all essential contractual information completely and accurately.  •  Amends already approved requisitions in ERP system (additional line item entries) as needed per contract amendments. •  Checks invoices against contracts upon receipt of invoice from either A/P or function responsible and forwards to technical individual in charge of approving the work performed in a timely manner. •  Upon receipt of work performed approval, secures any additional Functional Head approvals and enters invoice into ERP system for payment processing. •  Troubleshoots requisition entry issues as well as any invoice entry issues/errors (e.g. non-availability of pertinent Purchase Order numbers) in collaboration with finance and/or respon-sible functional leads to ensure speedy resolution of matter at hand and subsequent imple-mentation of corrective actions thereof as essential. •  Helps different functions know the status of payments to concerned vendors by coordinating with A/P and/or the R&D-FP&A Analyst per established systems and processes. •  Develops and maintains an efficient filing and tracking system to suitably retrieve entered requisitions, processed invoices and related contracts with ease when needed by various R&D-CMO functions (hard copies + e-copies). •  Creates new vendors in ERP system per established GSC/Finance processes.  Procures Forms W-9/W-8BIN as required and submits along with the vendor creation form to the ap-propriate GSC individual responsible for creating such vendors in ERP system. •  In partnership with Finance and Project Management, responsible for invoice payment data entry into identified Finance systems so as to track Health Care Provider (HCP) spend in compliance with the State and Federal Sunshine Act reporting obligations. •  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 •  A Bachelor’s degree from an accredited college or University is required. •  A minimum of 2-4 years of experience working in a regulated, process-oriented industrial environment is needed. Pharmaceutical industry experience especially in R&D constitutes an asset. •  Previous direct or indirect experience with Microsoft AX or other ERP systems 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.  •  Proven track record of organizational, interpersonal, prioritization and multi-tasking skills. •  Exceptional English language skills, both written and oral that enables quality communica-tions with various stakeholders, both inside as well as outside the Company. •  Commitment to goals with a positive “can do” approach to solving problems; team-player. •  Ability to thrive in a dynamic and fast-paced environment; highly process-oriented. •  Exhibits sound judgment, analytical acumen and concern for detail under pressure. •  Respects and understands tight schedules and ensures follow-up. •  Ability to maintain confidentiality, discretion, tact and diplomacy in all aspects of work. •  Strong customer service orientation. •  Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision. •  Proficient in Microsoft Office with advanced skills in Excel and Word.

Vice President, Clinical Development and Operations
Tue, 17 Jan 2012 01:54:59 GMT

VICE PRESIDENT, CLINICAL DEVELOPMENT AND OPERATIONS JOB SUMMARY The Vice President, Clinical Development and Operations will provide global leadership and stra-tegic direction for the clinical development of all Aptalis projects.  This position will act as the scientific point of reference for internal and external communications in regard to clinical devel-opment and operations matters.  As a member of Clinical and Regulatory Affairs senior manage-ment team, this position is responsible for developing and executing clinical research programs to support regulatory and/or marketing needs.  The Vice President, Clinical Development and Operations is accountable for compliance, and scientific and ethical integrity of all clinical research activities of the Company.  ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. Leadership and strategy •  Leads the clinical development and operation function including creating vision, strategy and setting goals for the department aligned with Company strategy. •  Establishes departmental priorities based on input, planning and coordination with other key stakeholders. •  Plans and delivers high-level clinical development and operations programs and strategies for products in the Company’s development portfolio. •  Builds solid relationships with all other departments to maximize success as a company in-cluding serving as a representative on internal committees (PWG, LAC, Medical Research & Grant Committee, PRC, publication committee). •  Builds and maintains an appropriately staffed, best in class department. •  Develops a strong and aligned development and operations team that interacts efficiently and professionally with investigators, site research personnel, scientists, clinical research organizations and other internal and external functions supporting clinical development and operations. •  Ensures high quality cross-departmental communication to enable proper decision-making. •  Chairs and manages the Protocol Review Committee. Execution of clinical development strategy •  Ensures that clinical development projects are properly planned, tracked, prioritized and sourced to maximize effective and efficient execution. •  Oversees and shapes design and implementation of clinical research programs and studies to support regulatory and/or marketing needs. •  Provides input into the lifecycle management strategies and implementation that maximize the commercial potential of the Company’s product portfolio. •  In collaboration with Finance, plans and tracks departmental budget and ensure spending is within agreed budget. •  Builds, maintains and coordinates relationships with external stakeholders, authorities and key opinion leaders, to fulfill clinical development and operations objectives and maximize the scientific value and efficiency of the clinical development projects. Builds and expands the Company’s pipeline •  Provides input from a clinical development and operations point of view on pipeline and commercial opportunities and makes appropriate recommendations to the CMO. Accountable for compliance, scientific and ethical integrity of clinical development projects and clinical research activities of the Company •  Accountable for creation and consistent application of clinical development and operations processes, such as protocol development and review, clinical research organization(s) selec-tion and management, study conduct and overall good clinical development practices. •  Reviews, approves and ensures compliance for the department with all applicable SOPs and the Company’s policies. •  Ensures all components are in place for quality control and quality assurance, as well as training of staff across the department; foster an environment that strives for best practices and consistent standards. •  Drives acquisition and implementation of state-of-the-art tools and processes to monitor compliance and performance of the department in general and in relations to each clinical development project. 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. •  Works effectively under deadlines. SUPERVISORY RESPONSIBILITY Produces value-added results through effective recruitment, delegation, performance manage-ment, training and development of employees in the following positions: •  Senior Director, Clinical Development •  Director, Clinical Development •  Director, Clinical Operations •  Associate Director, Statistics and Data Management Liaison •  Administrative Assistant EDUCATION AND/OR EXPERIENCE •  MD with a minimum of ten (10) years of industry experience in clinical development including a minimum of 5 years in a leadership position in this areas.  Experience working with GI products or board certification in a GI specialty, 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.  •  The ability to build and lead the clinical development and operations function in a fast paced, high growth, entrepreneurial environment. •  Understanding of the clinical research environment and healthcare market both in the U.S. and globally. •  Proven ability to build and maintain high value Key Opinion Leader (KOL) networks and pro-fessional relationships with the scientific community across a variety of therapeutic areas. •  Combines a strong medical orientation with business sense and pragmatism. •  Possesses a high degree of scientific and ethical integrity. •  Proven ability to drive decisions and manage in difficult business situations. •  Proven record of excellent verbal and written communication skills and networking ability. •  Proven leadership in a line function responsibility, as well as cross-functional/global teams. •  Ability to thrive in a dynamic and fast-paced environment. •  Ability to work effectively with strategic alliances/joint ventures. •  Excellent command of the English language. •  Proficient in Microsoft Office. •  Exceptional attention to detail and excellent organizational skills. •  Ability to accommodate up to 30% travel.

Analyst, Finance
Mon, 16 Jan 2012 15:43:59 GMT

ANALYST, FINANCE JOB SUMMARY The  Analyst, Finance  applies principles of accounting to compile information needed to close out the month and assist in the preparation of financial reports while utilizing appropriate accounting control procedures.  In addition, this position provides fundamental information that aids in the accurate review of net sales analysis. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Compiles financial information to prepare entries to accounts, such as general ledger and subsidiary ledger accounts •  Responsible for the analysis and reconciliation of various balance sheet accounts each month. •  Prepares and posts journal entries into the SAP/Microsoft AX system as needed. •  Reviews lockbox activity and prepares deposits for posting in SAP/Microsoft AX system. •  Generates daily cash report. •  Coordinates review of accounts receivable open items with the AR Associate to determine collectiblity. •  Calculates Monthly rebate lag (Governmental and Commercial). •  Generates quarterly returns lag calculations and analysis. •  Calculates monthly Chargeback lag. •  Assists in maintaining the monthly sales deductions, reserves calculations and analysis. •  Assists in the quarterly sales deduction rate verification. •  Assists in Distribution Services Agreement (DSA) calculations and analysis. •  Maintains fixed asset system and analysis and prepares monthly reconciliation. •  Performs monthly royalty calculation. •  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 A Bachelor’s degree from a four-year accredited college or university in Accounting; plus 4-5 years related experience in Accounting. CPA 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 Microsoft Office including advanced skills in Excel (Pivot tables, Vlookup, Macros, If Statements, Formulas).  SAP experience is strongly preferred. •  Possess strong analytical skills, attention to detail, math aptitude, and the ability to audit detailed reports to ensure accuracy of monthly close. . •  Ability to identify the critical issues or opportunities using appropriate information and solve or elevate issues according to reach and severity. •  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 to meet regular and critical deadlines. •  Exceptional attention to detail and excellent organizational skills. •  Ability to coordinate, contribute to and work within a cross-functional team. •  Ability to thrive in a dynamic and fast-paced environment. •  Demonstrated ability to clearly and accurately interpret and follow procedures and policies.

Manager, Sales Training - US Specialty Pharma
Thu, 12 Jan 2012 16:08:07 GMT

MANAGER, SALES TRAINING - US SPECIALTY PHARMA JOB SUMMARY The Manager of Sales Training is responsible for designing and developing curriculum for sales training classes and workshops at sales meetings.  Assists Senior Manager of Sales Training with Medical, Legal and Regulatory review of content and materials, managing vendor projects and implementing training programs for sales representatives. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Designs curriculum, training content and materials for new-hire sales representatives’ Initial Sales Training (IST) •  Design, curriculum, training content and materials for training programs for tenured representatives, including  but not limited to Intermediate (IMST) and Advanced (AST) sales training classes.  This includes the required pre-work, classroom content and pull-through application exercises.  •  Develops and coordinates pre-work and on-site training workshops for training the Aptalis field sales force, including but not limited to sales meetings and trade shows. •  Supports the Senior Manager Sales Training in the Medical, Legal and Regulatory review of sales training materials and content, including but not limited to submission, participation in review process and revision.  •  Provides assistance with vendor development to ensure sales training materials and workshops content aligns with sales and marketing objectives and the Integrity Selling model.  •  Develops and conducts professional training presentations on disease state, products, use of marketing materials and selling skills for remote and live training. •  Works closely with marketing to identify therapeutic training objectives and determine product learning continuums. •  Conducts field training sessions with representatives post sales training classes. Provides written progress reports to Senior Manager Sales Training and Sales Management; and representatives upon completion of each field visit. •  Exhibits solid coaching and mentoring skills that are constructive and motivational during field visits, remote and live classroom training of sales representatives. •  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 Bachelor’s degree from a four-year accredited college or university, plus five years pharmaceutical sales and pharmaceutical sales training experience are required.   Attending appropriate training classes to maintain and advance level of knowledge and skills for position will be required. 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.  •  Outstanding proven interpersonal, written and oral communication and presentation skills. •  Proven ability to adapt to different learning styles. •  Ability to deliver motivational presentations and translate learning concepts to diverse groups. •  Exhibits high level of professionalism and serves as outstanding role model. •  Proficiency in Microsoft Office including Word, Excel, and Power Point. •  Ability to coordinate, contribute to and work within a cross-functional team. •  Proven ability in timeliness and accuracy of administrative responsibilities. •  Excellent coaching and mentoring skills. •  Ability to thrive in a dynamic and fast-paced environment. •  Exceptional attention to detail and excellent organizational skills. •  Must be able to accommodate a minimum of 25% travel.  

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.

In-House Counsel, Commercial Operations
Mon, 14 Nov 2011 19:52:21 GMT

IN-HOUSE COUNSEL, COMMERCIAL OPERATIONS JOB SUMMARY The In-House Counsel – Commercial Operations provides a diverse range of legal services to the US commercial functions within the Company, which operates in an international and highly regu-lated environment. In particular, the In-House Counsel will help support the Sales Operations, Marketing, Meetings and Conventions, Trade, Managed Care and Customer Service functions. The In-House Counsel will prepare, review and assist in negotiating various types of commercial agreements. Key responsibilities also include support in the legal review of promotional material for the US market. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Provides general business law, marketing law and compliance-related advice to the identified functions and departments. •  Drafts, reviews and manages the conclusion of various contracts (i.e., managed care con-tracts, distribution agreements, consulting agreements, conventions related agreements, etc.) and other business related documents in support of the commercial functions’ business activities. •  Assists in the legal review of promotional material for the US market. •  Remains current on laws, rulings and regulations affecting business or within identified areas of responsibility and helps implement appropriate actions. •  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 under deadlines. EDUCATION AND/OR EXPERIENCE Member in good standing of a US bar, with four (4) to six (6) years of practice experience working in a corporate legal environment or a major law firm. Direct pharmaceutical industry experience is preferred. Experience in the areas of general commercial and contract law, marketing law and product liability are all relevant. 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.  •  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. •  Able to prioritize duties and manage multiple matters from start to finish with minimal supervi-sion. •  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 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 team.  

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.  

Marketing Manager
Sun, 28 Aug 2011 22:53:12 GMT

MARKETING MANAGER JOB SUMMARY The purpose of the Marketing Manager is to evaluate the Pharmaceutical Technologies business in support of the global Business Development and Licensing team objectives; identify issues and opportunities within the business; create and develop marketing programs to address these opportunities; and implement aligned tactics.  The Marketing Manager will interact with the commercial teams located in a number of Aptalis’ offices in the US and Europe; specifically members of Business Development, Licensing, Sales, Operations and R&D functions. ESSENTIAL DUTIES AND RESPONSIBILITIES The primary duties and responsibilities of this position include the following.  Other duties may be assigned. •  Manages multiple projects. •  Plans and develops tactics aligned with predefined strategies and establishes timelines and budgets for them •  Provides input on strategy and direction of the brand •  Identifies and pursues opportunities to drive business growth.  Identifies obstacles to busi-ness growth and works collaboratively to resolve them •  Manages overall and specific budgets and resources to achieve defined targets •  Monitors and evaluates competitive products and marketplace dynamics. Analyzes market data and information •  Develops marketing materials and obtains approval through the appropriate committees.  Works closely with BD and Licensing teams to ensure implementation. •  Works with agency partners to create, develop and implement tactical plans to meet defined timelines •  Develop conference strategy and oversee execution to achieve defined targets. •  Makes presentations to internal functions and management in various meetings •  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 BS/BA degree from a four-year accredited university or college in Science or Business  (MS in Marketing or MBA preferred); plus a minimum 5 years industry, and minimum 2 years mar-keting management experience 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.  •  Effectively manages and directs marketing agencies and vendors. •  Ability to work with a high degree of independence and self-initiative. •  Possesses high degree of self-confidence, intellectual curiosity, and positive attitude. •  Effectively prioritizes and spends time, and time of others, on critical topics and effectively adjusts plan of action as needs change. •  Proven ability to manage multiple tasks concurrently under aggressive timelines in a dynamic environment. •  Comfortable working across functional areas; team player who can work well with interna-tional cultures and diversity. •  Superior oral, written and presentation skills with comfort in communicating to all levels of management. •  Exceptional attention to detail and excellent organizational skills. •  Possesses experience managing and working within budgets. •  Proficient in Microsoft Office.  

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.  

Senior Director, Medical Affairs North America
Mon, 15 Aug 2011 20:27:39 GMT

SENIOR DIRECTOR, MEDICAL AFFAIRS, NORTH AMERICA JOB SUMMARY The Senior Director, Medical Affairs, North America is responsible for providing medical and scientific expertise and oversees all activities related to Medical Science Liaisons, Medical Information, Med Communication and Continuing Medical Education; builds and maintains relationships with Key Thought Leaders to increase organizations’ 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 Aptalis product marketed in NA    •   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 publishing and dissemination of scientific information related to marketed products.    •   Participates in producing the medical components of INDs, NDAs, and other FDA communications.    •   Oversees production and revision of AMCP dossiers and supports Managed Care with medical content and presentation to formularies    •   Oversees product promotional campaigns to ensure scientific/medical validity, including appropriate messaging of product benefit and warnings.    •   Acts as the chair of PARC.    •   Manages Continuing Medical Education programs to ensure educational programs that are accredited and of high quality and consistent with regulatory compliance requirements. •  KOL management:    •   Develops and maintains relationships with Key Thought Leaders through advisory boards, professional associations, and scientific meetings to achieve Aptalis objectives.    •   Provides support to Key Thought Leaders in publishing and presenting scientific findings.    •   Creates and manages ad hoc advisory boards for products.    •   Manages Medical Science Liaisons teams and develops MSL strategies.  •  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.   SUPERVISORTY RESPONSIBILITIES North American MSLs EDUCATION AND/OR EXPERIENCE University diploma in Medicine (MD). A minimum of (7) seven to ten (10) years' pharmaceutical or biotech industry experience in medical communications, added to proven experience in managing a scientific team.  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 with the Company’s various internal and external stakeholders. •  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. •  Facility to adapt to a rapidly changing environment. •  Proficiency in use of Microsoft Office. •  Excellent command of oral and written English.