Manager Medical Writing

Manager, Medical Writing

We are seeking a Manager, Medical Writing to play a hands‑on role in the development of regulatory and clinical documentation for an oncology‑focused pipeline. This position will have significant responsibility for regulatory submissions, including Module 2 summaries, and will partner closely with Regulatory Affairs, Clinical Development, and Biometrics.

$/yr – $/yr

• Author, review, and coordinate regulatory and clinical documents with a strong emphasis on submission content
• Lead development of Module 2 documents
  , including clinical summaries and overviews, in collaboration with Regulatory Affairs and Clinical Development
• Contribute to and support the preparation of IND, NDA, and BLA submissions
• Author and review clinical study protocols, clinical study reports, investigator brochures, and related documents
• Manage document planning, timelines, and review cycles across multiple programs or studies
• Ensure content is scientifically accurate, consistent, and aligned with regulatory expectations and company standards
• Partner cross-functionally with clinical, biometrics, pharmacovigilance, and regulatory teams to align on data interpretation and messaging
• Support continuous improvement of templates, writing processes, and documentation standards

• 4+ years of medical writing experience in industry, a CRO, academia, or a combination
• Demonstrated experience supporting regulatory submissions
  , including Module 2 content
• Oncology experience strongly preferred
• Advanced degree preferred (PhD, Pharm
  
  D, MD, or equivalent), but not required
• Solid understanding of ICH guidelines and global regulatory documentation standards
• Strong writing, editing, and organizational skills, with the ability to manage multiple deliverables concurrently

• Bay Area, CA or Princeton, NJ