Executive Director, Head of Medical Writing

About the role

The Executive Director, Head of Medical Writing is a strategic, hands-on leader responsible for leading and advancing the company’s Medical Writing function in support of its lead Phase 3 program, lanifibranor.

Key responsibilities

• Lead the medical writing function, including defining processes, standards, and document templates
• Develop and execute the medical writing strategy aligned with Phase 3 trial execution and regulatory submission plans (e.g., NDA/BLA/MAA)
• Serve as a key contributor to regulatory and clinical development strategy discussions
• Assess resourcing needs and manage external vendors/contract writers as needed
• Lead and/or author key documents, including:
• Clinical Study Reports (CSRs)
• Clinical protocols and amendments
• Investigator’s Brochures (IBs)
• Statistical Analysis Plans (SAPs) (in collaboration with Biostatistics)
• Clinical sections of NDA/BLA submissions (eCTD Module 2.5, 2.7 summaries)
• Regulatory responses and briefing documents
• Ensure documents meet FDA and other applicable regulatory guidelines
• Maintain consistency and clarity across documents supporting a single-asset program
• Facilitate document review cycles and manage stakeholder input efficiently
• Establish and maintain SOPs, style guides, and templates for medical writing
• Ensure quality control, clarity, and accuracy of all deliverables
• Ensure inspection-readiness of documentation

Qualifications

• Advanced degree (PhD, MD, PharmD, or equivalent) in life sciences or related field required
• 12+ years of medical writing experience in biotech/pharma
• Demonstrated experience supporting late-stage (Phase 3) clinical programs
• Proven track record contributing to NDA/BLA/MAA submissions
• Experience in small or mid-sized biotech environments strongly preferred
• Prior leadership experience or demonstrated ability to build and scale a function
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
• Strong team player that has a customer service approach and is solution oriented
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Possesses strong written and verbal communication skills
• Excitement about the vision and mission of Inventiva