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Medical Writing Director at Dyne Therapeutics — BranchFactor

Bachelor’s degree in life sciences or a related discipline required; advanced degree preferred, with a strong understanding of biochemistry and molecular biology principles
10+ years of medical writing experience in the pharmaceutical or biotechnology industry, with significant experience preparing clinical and regulatory documents
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
Demonstrated 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 related to document preparation, production, and submission, 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
Highly organized, with the ability to prioritize, manage multiple projects simultaneously, and deliver high-quality work under tight timelines
Detailed knowledge of requirements for key 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, with the ability to integrate input from multiple contributors into clear, cohesive, submission-ready documents

Medical Writing Director

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