Senior Director, Medical Writing

Your role

• Build and lead the global medical writing function to support clinical development programs through BLA submission and beyond.
• Develop and implement a strategic plan for the company’s medical writing activities, ensuring alignment with clinical development, regulatory affairs, and overall business goals.
• Define and implement a scalable medical writing strategy, including internal capabilities and external vendor partnerships.
• Develop and manage a fit-for-purpose operating model, including processes, technology tools, and functional standards.
• Partner with cross-functional leaders in Regulatory, Clinical Development, Clinical Operations, Biostatistics, and Quality to ensure submission readiness and alignment on documentation needs and timelines.
• Establish performance standards and provide leadership, mentoring, and oversight to writing staff and vendors.
• This role will be responsible for coordinating the review cycles of documents, managing all aspects of document development, and leading the project teams through the process, including any discussions on document revision, QC, and finalization.
• Collaborate with clinical development, regulatory affairs, biometrics, and related cross-functional teams to gather and integrate data into regulatory documents.

• Lead the planning, authoring, review, and finalization of core regulatory submission documents, including:
  • Clinical Study Reports (CSRs)
  • Module 2 (Clinical Overview and Clinical Summaries) and Module 5 documents for the BLA 
  • Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) 
  • Risk Management Plans, diversity plans, pediatric plans, and briefing documents
  • Annual reports and IND amendments 
  • Investigator Brochures (including IB updates) and annual DSURs, PSURs, PBRERs as appropriate
• Support Clinical Development in authoring, review, and finalization of protocols and protocol amendments, including quality review and publication readiness.  
• Ensure consistency, accuracy, and compliance with ICH, FDA, and EMA guidelines in all regulatory documentation.
• Drive document strategy discussions, timelines, and workflows to ensure all components of the BLA and all regulatory submissions are delivered on time and in high quality.
• Collaborate with Biostatistics and Data Management to ensure effective integration and presentation of clinical data.

• Ensure all documents meet internal and regulatory standards for scientific integrity, clarity, structure, and formatting.
• Establish and manage quality control and review processes to maintain inspection readiness and document traceability.
• Implement feedback loops from regulatory interactions and inspections to continuously improve writing processes.
• Lead lessons-learned efforts post-submission to evolve documentation practices.
• Directly contribute to cross-functional teams to integrate medical writing activities into overall project plans.

Your profile

• Advanced degree (PhD, PharmD, MS) in life sciences, health sciences, or a related field.
• Minimum of 12 years of experience in medical writing within the biotech/pharmaceutical industry, with significant experience leading BLA or NDA submissions.
• Oncology experience is preferred
• Proven experience managing end-to-end authorship of regulatory documents in support of late-stage clinical development.
• Strong understanding of global regulatory requirements, ICH guidelines, and industry standards.
• Demonstrated leadership in building and managing high-performing teams and external vendors.
• Excellent written and verbal communication skills with the ability to influence and collaborate cross-functionally.

Our offer