Head of Medical Writing (hybrid in Boston, MA)
We are seeking an experienced Head of Medical Writing to lead the strategy, development, and delivery of high-quality clinical and regulatory documents across all phases of drug development.
This role provides scientific and operational leadership for medical writing activities, supporting early- through late-stage programs and global regulatory submissions. The Head of Medical Writing will partner closely with Clinical Development, Regulatory Affairs, Biostatistics, and Safety to ensure accurate, timely, and compliant documentation.
Key Responsibilities
- Serve as the medical writing lead across one or more clinical programs
- Lead and/or author clinical documents including protocols, CSRs, and Investigator’s Brochures
- Support global regulatory submissions (INDs, NDA/BLA/MAA, health authority briefing documents, CTD Modules 2 and 5)
- Oversee timelines, coordinate cross-functional input, and ensure scientific accuracy and regulatory compliance
- Establish and maintain writing standards, templates, and best practices
- Facilitate efficient review cycles and ensure consistent scientific messaging across documents and programs
- Drive quality, process improvement, and scalable medical writing operations
Qualifications
- Advanced degree in life sciences (PhD, PharmD, MD, or MSc)
- 7–8+ years of medical writing experience in pharma, biotech, or CRO settingsStrong experience across multiple phases of clinical development and global regulatory submissions
- Proven leadership in complex writing projects and cross-functional environments
- In-depth knowledge of ICH, GCP, and global regulatory requirements
- Experience in oncology , rare disease, or other complex therapeutic areas preferred