Alerys | Rédacteur médical/Rédactrice médicale

ONE OF THE LARGEST R&D AND VACCINE PRODUCTION SITES IN THE WORLD IS LOOKING FOR A: Senior Medical Writer (M/F) (Full-time, permanent, 2 days per week remote, Rhône) THE CONTEXT The race is on to accelerate drug discovery and development to find answers for patients and their families One of the largest vaccine R&D and production sites in the world is strengthening its team to support the clinical development of its laboratories. Join a dynamic and multicultural team at the heart of innovative and international projects, contributing to the writing of essential documents in the field of clinical trials. YOUR ROLE Reporting to the Medical Writing Vaccine Manager, you will play a key role in writing, coordinating, and managing clinical and regulatory documents, ensuring their compliance with international standards and health agency requirements. Your main tasks will include: Writing and managing essential clinical documents: -Clinical trial protocols, CSR (Clinical Study Reports), ICF (Informed Consent Forms). -Investigator brochures and CTD (Clinical Trial Documents) files. -Briefing packages and other complex documents for regulatory submissions. Close collaboration with clinical development teams and partners (CROs). Active participation in the management of TMF (Trial Master Files) and data consolidation. Contribution to cross-functional working groups to ensure the quality and relevance of the documents produced. Provide an educational and popularization approach (simplification of key messages) to support: -Non-scientific teams (such as marketing and sales) and assist them in promoting and enhancing products, -Scientific and technical teams (Research, Pharmacovigilance, Regulatory Affairs, etc.) to foster cross-functional information sharing and influence strategic directions. YOUR PROFILE Essential: You hold a PhD or master’s degree in life sciences, pharmacy, or a related field, and have prior experience in medical writing, with expertise in clinical development, ideally acquired in a CRO or the pharmaceutical industry. This means you are familiar with clinical study methodologies and international regulatory requirements and can navigate complex environments. Of course, you have a strong knowledge of English, both written and spoken. How will you stand out? You can juggle long-term projects while maintaining unwavering attention to detail, and you’re a pro at collaboration THE A dynamic and collaborative team where intergenerational and multicultural diversity thrives. A strategic role within a global vaccine leader contributing to cutting-edge scientific projects, with exciting career development opportunities. The opportunity to follow long-term projects and request project changes as you progress. A variety of enriching tasks in a stimulating and collaborative environment. Are you craving new challenges in medical writing? Contact us if your curiosity is piqued Please send your CV in PDF format using the reference 24-101-02-LI to our consultant Lou SZABO, ALERYS Company – Our commitment: each application is carefully reviewed and handled by a qualified recruiter, not by artificial intelligence. We are committed to the human and personalized analysis of candidates' profiles, ensuring an equitable and non-discriminatory process.

Location: Rhône, FR

Posted Date: 1/9/2025