Senior Manager Medical Writing

Responsibilities:
- Produce high quality and on-time writing deliverables.
- Independently plan, write, edit, and format key clinical documents, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries, and related documents.
- Facilitate/manage efficient review and finalization of documents produced internally and/or externally by consultants, contractors, and vendors.
- Represent Medical Writing on multiple early phase project teams or specific late phase teams; collaborate with the Director of Medical Writing to ensure proper planning and resourcing for upcoming deliverables.
- Collaborate with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, and external stakeholders.
- Serve as a subject matter expert for clinical documents and their production.
- Contribute to SOP and template development and maintenance.

Qualifications:
- Bachelor’s degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise; advanced degree and/or professional certification/credentials preferred.
- 6+ years of experience as a medical writer in sponsor and/or CRO setting; experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus.
- In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Proven ability to manage multiple projects in a fast-paced, deadline-driven environment with strong attention to detail and timely completion.
- Experience overseeing contract writers is a plus; proficient with Microsoft Windows, Word, Excel, and PowerPoint.
- Ability to travel ~10%.

Application instructions: None provided.