Director, Medical Writing

🔥 21 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $190k - $235k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Dyne Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $300M Post-IPO Equity on 2026-07

Biotechnology • Healthcare • Pharmaceuticals

Dyne Therapeutics is a clinical-stage biotechnology company developing therapies for genetically driven neuromuscular diseases. Using its proprietary FORCE™ platform, Dyne designs precision therapeutics aimed at addressing the root causes of conditions such as Duchenne muscular dystrophy (DMD), myotonic dystrophy type 1 (DM1), and facioscapulohumeral muscular dystrophy (FSHD). The company maintains an active clinical pipeline (including assets named Zeleciment rostudirsen/DYNE-251, Zeleciment basivarsen/DYNE-101, and DYNE-302), runs clinical trials, and emphasizes patient-centered development and community engagement.

📋 Description

• 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

• 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

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