Director, Medical Writing
Dyne Therapeutics
July 02, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Role Summary
- Responsible for timely preparation of high quality, compliant clinical and regulatory documents.
- Medical writing for one or more clinical programs; interacts with cross-functional teams (clinical development, operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs).
- Functions with limited supervision; ensures deliverables are high quality and on time per SOPs, ICH/GCP/regulatory guidelines, and company goals.
- Lead strategic discussions to ensure aligned messaging throughout regulatory documentation.
- Based in Waltham, MA with hybrid work flexibility.
Primary Responsibilities
- Writes, edits, and collaborates on regulatory documents (protocols, investigator brochures, clinical study reports, CTDs, briefing books).
- Reviews/edits documents or sections prepared by functional area representatives; ensures quality and adherence to standards.
- Oversees document review comment resolution meetings.
- Contributes to project management and cross-functional working groups for efficient document development and submission finalization.
- Supports development of best practices for authoring/reviewing and continuous process improvement.
Education and Qualifications/Skills Requirements
- Bachelor’s degree (advanced degree preferred) in Life Sciences or related discipline; solid understanding of biochemistry and molecular biology.
- Minimum 5 years writing clinical/regulatory documents for a pharmaceutical/biotech company.
- Competence writing/editing/reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents.
- Knowledge of FDA/international regulations, ICH guidelines, and regulatory processes for document preparation/production (including CTDs).
- Proficiency with Microsoft Office, Adobe Acrobat; shared systems (SharePoint, Veeva).
- Ability to work independently, prioritize, problem-solve, and meet aggressive timelines; detail-oriented and accurate.
- Aptitude for data compilation, analysis, and presentation; ability to produce unified documents with multiple contributors.
Salary Range
- $194,000 - $213,000 USD.
- Responsible for timely preparation of high quality, compliant clinical and regulatory documents.
- Medical writing for one or more clinical programs; interacts with cross-functional teams (clinical development, operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs).
- Functions with limited supervision; ensures deliverables are high quality and on time per SOPs, ICH/GCP/regulatory guidelines, and company goals.
- Lead strategic discussions to ensure aligned messaging throughout regulatory documentation.
- Based in Waltham, MA with hybrid work flexibility.
Primary Responsibilities
- Writes, edits, and collaborates on regulatory documents (protocols, investigator brochures, clinical study reports, CTDs, briefing books).
- Reviews/edits documents or sections prepared by functional area representatives; ensures quality and adherence to standards.
- Oversees document review comment resolution meetings.
- Contributes to project management and cross-functional working groups for efficient document development and submission finalization.
- Supports development of best practices for authoring/reviewing and continuous process improvement.
Education and Qualifications/Skills Requirements
- Bachelor’s degree (advanced degree preferred) in Life Sciences or related discipline; solid understanding of biochemistry and molecular biology.
- Minimum 5 years writing clinical/regulatory documents for a pharmaceutical/biotech company.
- Competence writing/editing/reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents.
- Knowledge of FDA/international regulations, ICH guidelines, and regulatory processes for document preparation/production (including CTDs).
- Proficiency with Microsoft Office, Adobe Acrobat; shared systems (SharePoint, Veeva).
- Ability to work independently, prioritize, problem-solve, and meet aggressive timelines; detail-oriented and accurate.
- Aptitude for data compilation, analysis, and presentation; ability to produce unified documents with multiple contributors.
Salary Range
- $194,000 - $213,000 USD.