Role Summary:

The Director, Medical Writing provides strategic leadership and hands-on execution for the development of high-quality, compliant clinical and regulatory documents supporting one or more development programs. This role partners closely with Clinical Development, Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Research, Preclinical, Translational Biomarkers, Program Management, and Medical Affairs to ensure clear, consistent scientific messaging across key submissions to the FDA and global health authorities. Operating with a high degree of independence, the Director drives document planning, authoring, review, and finalization in alignment with company priorities, SOPs, ICH/GCP guidance, and applicable regulatory requirements.

This role can be based in Waltham, MA or remotely.

Primary Responsibilities Include:

• 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

Education and Skills 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