Director, Medical Writing

GlobeNewswire

Director of Medical Writing at Dyne Therapeutics responsible for regulatory documents preparation and collaboration across teams. Requires expertise in clinical writing and regulatory compliance.

Posted 7/2/2026full-timeWaltham • Massachusetts • 🇺🇸 United StatesLead💰 $194,000 - $213,000 per yearWebsite

About the role

Key responsibilities & impact

Writes, edits, and collaborates with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, CTDs, and briefing books
Reviews, edits, and ensures quality of documents or sections of documents prepared by functional area representatives as required and ensures adherence to standards
Oversees document review comment resolution meetings
Contributes to overall project management and to cross-functional working groups as needed to facilitate efficient development and finalization of clinical and regulatory documents for submissions
Supports the development of best practices for authoring and reviewing, with a focus on continuous process improvement

Requirements

What you’ll need

Minimum of a Bachelor’s degree (advanced degree preferred) in Life Sciences, or related discipline, with a solid understanding of the basic principles of biochemistry and molecular biology
Minimum 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company
Competence in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents per company and other guidelines
Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
Proficiency with typical office applications (eg, Microsoft Office, Adobe Acrobat) and in shared document systems (eg, SharePoint, Veeva)
Ability to work independently: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines
Aptitude for compilation, analysis, and presentation of data
Ability to work with multiple contributors to produce a final unified document
Commitment to accuracy and detail-oriented work.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account GlobeNewswire Website LinkedIn All Job Openings 1001 - 5000 employees Built for PR, IR,marketing and agency professionals, GlobeNewswire by Notified gives you a wide range of options to help you build brand awareness, reach new audiences, and drive earned media.GlobeNewswire distributes press releases and multimedia content on behalf of thousands of customers every year, including growing businesses, agencies, non-profits, and many of the world’s largest public companies. We have options to fit your specific needs and budget, and editorial services that are second to none.Visit GlobeNewswire.com to learn more. Director, Medical Writing Job not on LinkedIn 🔥 3 minutes ago 🏢🏡 Waltham – Hybrid 💵 $194k - $213k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Writes, edits, and collaborates with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, CTDs, and briefing books
Reviews, edits, and ensures quality of documents or sections of documents prepared by functional area representatives as required and ensures adherence to standards
Oversees document review comment resolution meetings
Contributes to overall project management and to cross-functional working groups as needed to facilitate efficient development and finalization of clinical and regulatory documents for submissions
Supports the development of best practices for authoring and reviewing, with a focus on continuous process improvement 🎯 Requirements
Minimum of a Bachelor’s degree (advanced degree preferred) in Life Sciences, or related discipline, with a solid understanding of the basic principles of biochemistry and molecular biology
Minimum 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company
Competence in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents per company and other guidelines
Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
Proficiency with typical office applications (eg, Microsoft Office, Adobe Acrobat) and in shared document systems (eg, SharePoint, Veeva)
Ability to work independently: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines
Aptitude for compilation, analysis, and presentation of data
Ability to work with multiple contributors to produce a final unified document
Commitment to accuracy and detail-oriented work. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

Clinical Study Report WritingProtocol DevelopmentCTD Module PreparationInvestigator Brochure WritingDocument EditingRegulatory Document ReviewData AnalysisQuality AssuranceProcess ImprovementDocument Compilation

Soft Skills

Attention to DetailProblem SolvingIndependent WorkCollaborationTime Management