Senior Manager, Medical Writing
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Job Description
Sr. Manager, Medical Writing preparing clinical regulatory documents for neurobiopharmaceutical treatments. Leading interdisciplinary teams for high-quality submissions and managing regulatory writing processes.
Responsibilities:
- Prepares and reviews clinical/regulatory documents to support all phases of drug development
- Leading the writing activities for all regulatory documents for a project team
- Identifying and managing contractors
- Planning activities for New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs)
- Building and managing the submission writing team
- Authors and manages the authoring process for all clinical/regulatory documents
- Leads and provides subject matter expertise to the core authoring team
- Ensures document content is clear, concise, strategic, and well positioned for public disclosure
- Supports authoring best practices and provides continued training to teams
- Represents Medical Writing Department on project teams
- Mentor and may manage internal staff
Requirements:
- BS/BA degree in the life sciences or related field AND 8+ years of medical writing or related experience required
- Experience leading an NDA/MAA or authoring key documents supportive of either
- MS/MA degree in a life sciences or related field preferred AND 6+ years of experience as noted above
- PhD in a life sciences or related field preferred AND 4+ years of experience as noted above
- Previous managerial / functional management experience also required
- Excellent team player who can effectively navigate differing opinions and personalities
- Strong skills in leadership, communication and creativity
- Excellent project management skills, including managing simultaneous projects
- Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools
- General understanding of statistics
- Broad understanding of the medical writing processes, procedures, and systems
Benefits:
- Retirement savings plan (with company match)
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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