Medical Writing Director

This role requires 3 days per week in Waltham, MA office.
The Medical Writing Director provides strategic, scientific, and operational leadership for all clinical and regulatory writing activities across the company’s global development programs. This role is responsible for setting the vision, standards, and processes for medical writing, and for ensuring the delivery of high-quality, compliant, and compelling documentation that supports clinical development, regulatory submissions, and interactions with global health authorities.

The Medical Writing Director will oversee the end-to-end authoring, planning, and management of complex regulatory documents—including clinical study protocols, clinical study reports (CSRs), Investigator’s Brochures (IBs), Development Safety Update Reports (DSURs), and global regulatory submissions (e.g., IND, CTA, NDA/BLA, and major meeting packages). This leader will collaborate cross-functionally at strategic and operational levels, influence regulatory strategy, and build and develop a high-performing internal and external medical writing organization.

• Establish and lead the medical writing function, setting long-term strategy, standards, and best practices across all programs.
• Serve as the expert in medical writing, providing strategic guidance on document strategy, data presentation, messaging consistency, and regulatory expectations.
• Collaborate with clinical and regulatory leadership to anticipate upcoming submission needs and ensure organizational readiness.
• Develop, maintain, and enforce document standards, templates, style guides, and best practices to ensure high-quality deliverables across all programs.
• Oversee and/or directly author the planning, development, and delivery of critical regulatory and clinical documents, including: Clinical Study Protocols and Amendments, CSRs, IBs, DSURs, IND Modules, and regulatory meeting packages.
• Ensure scientific accuracy, clarity, and consistency of messaging aligned with regulatory strategy and clinical objectives across all programs.
• Lead document planning for major submissions, including timelines, resourcing, and cross-functional integration.
• Partner closely with Clinical Development, Regulatory Affairs, Data Sciences, Pharmacovigilance, CMC, Nonclinical, Program Management, and senior leadership to gather inputs and ensure alignment.
• Provide expert-level guidance on the structure, content, and strategy for clinical and regulatory documents.
• Play a central role in regulatory submission planning, cross-functional review processes, and regulatory meeting preparation.
• Oversee vendor selection, budget management, and performance oversight for outsourced writing activities.
• Lead the creation, implementation, and continuous refinement of templates, document workflows, and electronic document systems.
• Drive improvements in document processes, including automation, digital tools, and submission-readiness practices.
• Ensure deliverables meet all applicable industry standards, including ICH, FDA, EMA, and regional authority requirements.