Dynetherapeutics
Director, Medical Writing
Remote. Posted 10 days ago
The role
The Director, Medical Writing provides strategic leadership and hands-on execution for clinical and regulatory documents. This person will partner with cross-functional teams to ensure consistent scientific messaging for FDA and global health authority submissions.
What you will do
- 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
- Author, edit, and collaborate on protocols, investigator brochures, clinical study reports, CTD modules, and briefing books
- Review and refine documents prepared by functional contributors
- Contribute to project planning and cross-functional working groups
- Establish and improve medical writing processes, templates, and best practices
Required qualifications
- Bachelor's degree in life sciences or a related discipline
- 10+ years of medical writing experience in the pharmaceutical or biotechnology industry
- Significant experience preparing clinical and regulatory documents
- Deep experience authoring and reviewing clinical and regulatory documents
- Ability to lead strategic discussions that align content and messaging across submissions
- Exceptional communication skills to influence cross-functional stakeholders
- Experience overseeing internal and external medical writing resources, including vendors, consultants, and cross-functional contributors
- Demonstrated expertise writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents
- Strong understanding of FDA and international regulations, ICH guidelines, and regulatory processes
- Experience developing and executing medical writing strategy across programs, submissions, or therapeutic areas
- Proficiency with Microsoft Office, Adobe Acrobat, and shared document management systems such as SharePoint
- Highly organized, with the ability to prioritize and manage multiple projects simultaneously
Nice to have
- advanced degree preferred
- strong understanding of biochemistry and molecular biology principles
About the company
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for other diseases.