Director, Medical Writing
Dyne Therapeutics
July 02, 2026
Remote
United States
Clinical Research and Development
Role Summary
The Director, Medical Writing provides strategic leadership and hands-on execution for the development of high-quality, compliant clinical and regulatory documents supporting one or more development programs.
Primary Responsibilities:
- Lead the planning, authoring, review, and completion of clinical and regulatory documents required for submissions to the FDA and other global health authorities
- Manage internal and external medical writing resources to deliver accurate, high-quality documents on time and in accordance with established standards
- Author, edit, and collaborate with cross-functional team members on key documents (protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and submission materials)
- Review and refine documents/sections prepared by functional contributors to ensure quality, consistency, scientific accuracy, and adherence to company and regulatory standards
- Contribute to project planning and cross-functional working groups to support efficient development through submission-ready finalization
- Establish and continuously improve medical writing processes, templates, and best practices
Education & Qualifications:
- Bachelor’s degree in life sciences or related discipline required; advanced degree preferred
- 10+ years of medical writing experience in pharmaceutical/biotechnology with significant clinical and regulatory document preparation experience
Required/Preferred Skills & Experience:
- Deep experience authoring and reviewing clinical and regulatory documents
- Strong understanding of FDA and international regulations, ICH guidelines, and CTD/document submission processes
- Experience developing and executing medical writing strategy across programs/submissions/therapeutic areas
- Ability to lead strategic discussions and influence cross-functional stakeholders
- Experience overseeing internal/external writing resources (vendors/consultants/contributors)
- Proficiency with Microsoft Office, Adobe Acrobat, and SharePoint (or similar)
Location: Waltham, MA or remote
Pay Range: $190,000 - $235,000 USD
The Director, Medical Writing provides strategic leadership and hands-on execution for the development of high-quality, compliant clinical and regulatory documents supporting one or more development programs.
Primary Responsibilities:
- Lead the planning, authoring, review, and completion of clinical and regulatory documents required for submissions to the FDA and other global health authorities
- Manage internal and external medical writing resources to deliver accurate, high-quality documents on time and in accordance with established standards
- Author, edit, and collaborate with cross-functional team members on key documents (protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and submission materials)
- Review and refine documents/sections prepared by functional contributors to ensure quality, consistency, scientific accuracy, and adherence to company and regulatory standards
- Contribute to project planning and cross-functional working groups to support efficient development through submission-ready finalization
- Establish and continuously improve medical writing processes, templates, and best practices
Education & Qualifications:
- Bachelor’s degree in life sciences or related discipline required; advanced degree preferred
- 10+ years of medical writing experience in pharmaceutical/biotechnology with significant clinical and regulatory document preparation experience
Required/Preferred Skills & Experience:
- Deep experience authoring and reviewing clinical and regulatory documents
- Strong understanding of FDA and international regulations, ICH guidelines, and CTD/document submission processes
- Experience developing and executing medical writing strategy across programs/submissions/therapeutic areas
- Ability to lead strategic discussions and influence cross-functional stakeholders
- Experience overseeing internal/external writing resources (vendors/consultants/contributors)
- Proficiency with Microsoft Office, Adobe Acrobat, and SharePoint (or similar)
Location: Waltham, MA or remote
Pay Range: $190,000 - $235,000 USD