Astellas is announcing a Medical Writing Program Manager opportunity in Northbrook, IL.
Purpose & Scope:
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; 7+ years relevant experience or 5 years with Master's degree. Preferred: MS/MA/MPH; at least 5 years as writing professional in pharmaceutical industry.
- Must have substantive medical writing experience in the therapeutic area of Oncology
- 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, biopharmaceutics, 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.
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