Director, Medical Writing

Responsibilities

• Lead the planning, authoring, review, and completion of clinical and regulatory documents for FDA and global health authority submissions
• Manage internal and external medical writing resources to ensure high-quality, timely delivery
• Author and edit key documents including protocols, investigator brochures, clinical study reports, and CTD modules
• Review and refine documents from functional contributors to ensure scientific accuracy and regulatory adherence
• Establish and improve medical writing processes, templates, and best practices

Requirements

• Bachelor’s degree in life sciences or related discipline (advanced degree preferred)
• 10+ years of medical writing experience in pharmaceutical or biotechnology industries
• Deep expertise in authoring and reviewing clinical and regulatory documents (protocols, CSRs, IBs, CTD modules)
• Strong understanding of FDA/international regulations, ICH guidelines, and CTD requirements
• Experience managing vendors, consultants, and cross-functional contributors
• Proficiency with Microsoft Office, Adobe Acrobat, and SharePoint
• Ability to synthesize complex clinical and scientific data clearly

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, targeting the muscle and central nervous system to address the root cause of disease.