RBW Consulting is hiring: AD/Director Medical Writing in Boston

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