Senior Manager, Medical Writing

Job Summary

To provide regulatory medical writing support for development programs, the full-time Senior Manager, Medical Writing will independently author and finalize complex regulatory documents while collaborating with cross-functional teams in a remote work environment.

Key responsibilities

• Independently author, edit, and finalize complex regulatory documents to ensure scientific accuracy and compliance with regulatory requirements
• Lead the development of FDA briefing documents and contribute to clinical protocol development for studies
• Collaborate with various functional teams to gather and synthesize scientific and clinical information while managing document development timelines

Required qualifications

• Advanced degree (PhD, PharmD, MD, MS, or equivalent) in Life Sciences, Pharmacy, Medicine, or a related scientific discipline preferred
• 10+ years of medical writing experience within the biotechnology or pharmaceutical industry
• Extensive experience independently authoring FDA regulatory documents, including briefing packages and clinical development documents
• Proven experience developing FDA briefing documents supporting RMAT, Breakthrough Therapy Designation, or similar regulatory interactions
• Strong experience writing clinical protocols and protocol synopses