AD/Director Medical Writing Job at RBW Consulting in boston
RBW Consulting, boston, ma, United States
A clinical stage biotech company is seeking a senior Medical Writer to support key regulatory submissions and oncology clinical programs. This is a hands‑on role for an experienced writer who is comfortable managing end‑to‑end document development and cross‑functional coordination, with the potential to grow into the Head of Medical Writing.
Responsibilities
- Lead writing and preparation of FDA submission components, clinical protocols, study reports, and related documents
- Coordinate timelines, reviews, and content across Clinical, Regulatory, and Biostats
- Ensure high quality, compliant documentation throughout development
- Provide hands on writing support while helping shape the medical writing function
- Opportunity to grow into a future department leadership role
Qualifications
- 8 or more years of medical writing experience in pharma or biotech
- Strong background in FDA submissions and clinical regulatory documentation
- Oncology experience required
- Highly organized, detail oriented, and willing to handle both strategic and tactical work