Astellas Pharma Medical Writing Program Manager in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Medical Writing Program Manager opportunity in Northbrook, IL.
Purpose & Scope of Position:
Acts as a Global Medical Writing Lead (GMWRL; medical writing representative on a global project team) for several early-stage development programs and/or acts as a back-up/supporting GMWRL. The individual provides project leadership with respect to program documents and writing activities commensurate with experience. The individual reviews work and manages/coordinates writing activities for an entire program. As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team.
Essential Job Responsibilities:
- Acts as a primary GMWRL generally for several early-stage development projects and/or acts as a back-up/supporting GMWRL for several early-stage development projects. Examples of back-up/supporting activities are substituting at global project team meetings for primary GMWRL (including strategic sessions if the primary GMWRL is unavailable), and undertaking a GMWRL task/responsibility for a program at the request of the primary GMWRL.
- As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team. (Contribution will be commensurate with experience.)
- Reviews work and manages/coordinates writing activities for an entire program, contributing to the successful completion of required program documents.
- For some of the document types within a program, implements adjustments in specific document content within framework of provided templates in order to fit needs of a specific document/core team requirements (other documents may require advice from senior staff).
- Participates in departmental project activities (up to a total of 3% of time).
- For a Contract Research Organization (CRO) working on a program, collects, monitors and maintains metrics associated with document creation and quality review, including individual performance evaluation, and provides the information to Line Management in order to improve CRO alliance management.
- In addition to GMWRL responsibilities, may act as a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a project not within the scope of program responsibilities as a result of being a recognized expert for the document type.
- Contributes to the quality and performance of CROs and staff, impacting costs and program success.
- Directly or indirectly responsible for oversight of MW activities, through CRO alliances and performance management, with budgets up to $1.5M/year per program.
- Ensures support of Astellas global project team strategies and program success by contributing as a document specialist with advice from more senior staff.
- Project track, program responsibility role.
- May lead a team of individuals including staff and CRO (e.g., writer, Document Working Group Facilitator [DWGF]).
- BA/BS degree or equivalent; 7+ years relevant experience or 5 years with Master's degree. Preferred: MS/MA/MPH or equivalent; at least 5 years as writing professional in pharmaceutical industry.
- Activities require expert technical skill (e.g., as defined by Drug Information Association Medical Writing Competency Model) including techniques of scientific writing and editing; ability to interpret and communicate clinical and numerical data, and verify consistency in data; comprehend and communicate scientific concepts; interpret and communicate clinical, nonclinical, biopharmaceutic, pharmacology, ADME and CMC data and information.
- Activities require advanced document and process experience, and routinely requires highly complex problem solving/issue resolution to achieve corporate objective(s).
- Technical expert on a number of document types. Demonstrated and substantial experience in managing the creation of IND/IMPD or NDA/MAA components.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Data Science