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Director, Medical Writing
Location
Massachusetts
Posted
4 days ago
Salary
$190K - $235K / year
Seniority
Lead
Job Description
Director, Medical Writing
GlobeNewswire
• Lead the planning, authoring, review, and completion of clinical and regulatory documents required for submissions to the FDA and other global health authorities • Manage internal and external medical writing resources to deliver accurate, high-quality documents on time and in accordance with established standards • Author, edit, and collaborate with cross-functional team members on key documents, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials • Review and refine documents or document sections prepared by functional contributors to ensure quality, consistency, scientific accuracy, and adherence to company and regulatory standards • Contribute to project planning and cross-functional working groups to support efficient development, review, approval, and finalization of submission-ready documents • Establish and continuously improve medical writing processes, templates, and best practices to increase quality, consistency, and operational efficiency
Job Requirements
- 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.
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