Head of Medical Writing

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 settings
Strong 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

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