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Astellas is announcing a Senior Medical Writing Program Manager, Oncology opportunity in our Deerfield, IL location.

Acts as a Global Medical Writing Lead (GMWRL; medical writing representative on a global project team) generally for early- to mid-stage development global project teams and may act as a back-up/supporting GMWRL for several projects. 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 across an entire program, and may review and amend the work plans developed by a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a particular document. The individual provides intellectual leadership and contributes document knowledge and expertise to the project team.

Acts as a primary GMWRL generally for a number of global early- to mid-stage development projects.
May act as a back-up/supporting GMWRL for several projects, including mid- to late-stage 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 activities for an entire program so as to contribute to successful completion of required program documents. May review and amend the work plans developed by a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a particular document.
For the majority of document types within a program, implements adjustments in specific document content within framework of provided templates in order to fit the needs of a specific document/core team requirements (some documents require advice from senior staff).
Participates in departmental project activities (up to a total of 5% of time).
For a Contract Research Organization (CRO) working on program, evaluates/analyzes 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 Medical Writing activities, through CRO alliances and performance management, with budgets up to $2M/year per program.
Ensures support of Astellas global project team strategies, and program success by monitoring performance, reviewing work, and contributing as a document specialist with advice from more senior staff.  
Organizational context:

• Project track, program responsibility role.
• May lead a team of individuals including staff and CRO (e.g., Working Group Facilitator [DWGF]; writer).
 

Position Requirements BA/BS degree or equivalent; 10+ years relevant experience. Preferred: MS/MA/MPH with at least 7 years as a 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 highly complex problem solving/issue resolution to achieve corporate objective(s), resourcefulness and sharing of expertise.
Technical expert for the majority of document types produced by medical writing. Demonstrated and substantial experience in managing the creation of IND/IMPD or NDA/MAA components, briefing documents and white papers.
 
 

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