Director, Medical Writing
New
D
Dyne TherapeuticsBiotechnology
This role can be based in Waltham, MA or remotely.Full-TimeDirector
Salary190,000 - 235,000 USD per year
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Job Details
- Experience
- 10+ years
- Required Skills
- SharePointMicrosoft Office
Requirements
- Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
- 10+ years of medical writing experience in the pharmaceutical or biotechnology industry.
- Deep experience authoring and reviewing clinical and regulatory documents.
- Demonstrated expertise writing, editing, and reviewing protocols, clinical study reports, investigator brochures, and CTD modules.
- Strong understanding of FDA and international regulations, ICH guidelines, and regulatory processes.
- Experience overseeing internal and external medical writing resources including vendors and consultants.
- Experience developing and executing medical writing strategy across programs and submissions.
- Proficiency with Microsoft Office, Adobe Acrobat, and shared document management systems like SharePoint.
- Highly organized with the ability to manage multiple projects simultaneously under tight timelines.
- Ability to synthesize, analyze, and present complex clinical and scientific data clearly and accurately.
- Strong collaboration and communication skills to influence cross-functional stakeholders.
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, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials.
- Review and refine documents or document 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, review, approval, and finalization of submission-ready documents.
- Establish and continuously improve medical writing processes, templates, and best practices.
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