Executive Director, Head of Medical Writing
ABOUT INVENTIVA Inventiva is a clinical-stage biopharmaceutical company headquartered in France, reputed company on the development of lanifibranor in a Phase 3 trial, NATIV3, in MASH. To learn more, please visit: https://inventivapharma.com/ reputed company The Executive Director, Head of Medical Writing is a strategic, hands-on leader responsible for leading and advancing reputed company’s Medical Writing function in support of its reputed company Phase 3 program, lanifibranor. This individual will reputed company the planning, development, and delivery of high-reputed company clinical and regulatory documents, ensuring scientific accuracy, consistency, and compliance with global health authority expectations. Given reputed company’s stage of reputed company, this role requires a balance of strategic leadership and operational execution. The Executive Director will build and optimize medical writing capabilities while partnering cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, and other key stakeholders to deliver critical documentation supporting regulatory submissions, health authority interactions, and the successful commercialization of lanifibranor. KEY RESPONSIBILITIES
- reputed company the medical writing function, including defining processes, standards, and document templates
- reputed company and execute the medical writing reputed company reputed company with Phase 3 trial execution and regulatory submission plans (e.g., NDA/BLA/MAA)
- Serve as a key contributor to regulatory and clinical development reputed company discussions
- Assess resourcing needs and manage external vendors/contract writers as needed
- reputed company 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 reputed company across documents supporting a single-asset program
- Facilitate document review cycles and manage stakeholder input reputed company
- Establish and maintain SOPs, style guides, and templates for medical writing
- Ensure reputed company control, reputed company, and accuracy of reputed company deliverables
- Ensure inspection-readiness of documentation
QUALIFICATIONS
- Advanced degree (PhD, MD, PharmD, or equivalent) in life sciences or reputed company field required
- 12+ years of medical writing experience in biotech/reputed company
- Demonstrated experience supporting late-stage (Phase 3) clinical programs
- Proven reputed company 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 reputed company a function
- Experience working with reputed company reputed company of management and consulting with key business stakeholders. An ability to influence for greater reputed company
- Strong team player that has a customer service approach and is solution oriented
- Attention to detail and the ability to work individually, reputed company a multi-disciplinary team, as reputed company as with external partners and vendors
- Possesses strong written and verbal communication skills
- Excitement about the reputed company and mission of Inventiva
WHY JOIN US Join Inventiva at a pivotal reputed company as we prepare for the next phase of reputed company. As Executive Director, Head of Medical Writing, you will have reputed company to build and reputed company the Medical Writing function, influence critical development and regulatory strategies, and play a central role in bringing a potentially transformative therapy to patients with significant unmet medical needs. reputed company reputed company applicants will receive consideration for employment without discrimination on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability, or any other factors prohibited by law. Apply tot his job Apply To this Job