Director, Medical Writing

Dyne Therapeutics

. Provide strategic leadership and hands-on execution for high-quality, compliant clinical and regulatory documents supporting development programs .

Posted 11/3/2026full-timeRemote • Massachusetts • United StatesLead💰 $190,000 - $235,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in authoring and reviewing clinical and regulatory documents, with a strong understanding of FDA regulations and ICH guidelines. Proven ability to lead strategic discussions and manage cross-functional collaborations to ensure high-quality submissions.

Highest-signal resume keywords

Medical Writing ExperienceClinical Regulatory Documents ExpertiseFDA Regulations KnowledgeProject Management SkillsExceptional Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical WritingDocument ReviewClinical Study ReportsProtocols AuthoringCTD ModulesInvestigator BrochuresRegulatory SubmissionsStrategic PlanningData AnalysisQuality Assurance

Soft Skills

CollaborationAttention to DetailProblem SolvingInfluencing StakeholdersSelf-Directed

Tools & Technologies

Microsoft OfficeAdobe AcrobatSharePointDocument Management Systems

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryICH GuidelinesINDsCTAsRegulatory ProcessesCross-Functional TeamsMedical Affairs

About the role

Key responsibilities & impact

Provide strategic leadership and hands-on execution for high-quality, compliant clinical and regulatory documents supporting development programs
Partner with Clinical Development, Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Research, Preclinical, Translational Biomarkers, Program Management, and Medical Affairs
Lead planning, authoring, review, and completion of documents for FDA and global health authority submissions
Manage internal and external medical writing resources to deliver accurate, high-quality documents on time
Author, edit, and collaborate on protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials
Review and refine contributor-prepared documents for quality, consistency, scientific accuracy, and regulatory adherence
Contribute to project planning and cross-functional working groups
Establish and improve medical writing processes, templates, and best practices

Requirements

What you’ll need

Bachelor’s degree in life sciences or a related discipline required; advanced degree preferred
10+ years of medical writing experience in the pharmaceutical or biotechnology industry
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
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, including CTD requirements
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
Ability to prioritize, manage multiple projects simultaneously, and deliver high-quality work under tight timelines
Detailed knowledge of requirements for clinical, nonclinical, and regulatory documents supporting INDs, CTAs, annual reports, and related submissions
Strong attention to detail, accuracy, and consistency
Ability to synthesize, analyze, and present complex clinical and scientific data clearly and accurately
Self-directed, proactive, and effective at problem solving in a fast-paced, cross-functional environment
Strong collaboration skills and ability to integrate input from multiple contributors into submission-ready documents