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.
Base pay range
$150,000.00/yr – $170,000.00/yr
Key Responsibilities
- 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
Qualifications
- 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, PharmD, 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
Location (hybrid on‑site model)
- Bay Area, CA or Princeton, NJ