* Acts as a primary GMWRL generally for several early-stage development projects and/or acts as a backup/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 Masters 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.
* Medical, Dental and Vision insurance
* Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
* 401(k) Match and Annual Company Contribution
* Company Paid Life Insurance
* Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
* Long Term Incentive Plan for eligible positions
* Referral bonus program
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Tagged as: United States
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