Senior Medical Writer

il y a 2 semaines


Paris, France Excelya Temps plein

Senior Medical Writer Join to apply for the Senior Medical Writer role at Excelya. As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects and work alongside industry experts to enhance scientific knowledge and improve the patient journey. About the Job We are seeking a Senior Medical Writer to produce medical writing deliverables (both regulatory and medical communication documents). Main Activities Ensure compliance with sponsors' and Excelya's SOPs, guidelines, and relevant legislation. Stay updated on changes in industry standards, laws, and procedures. Conduct literature reviews aligned with project and sponsor requirements. Write, edit, and review a wide range of medical documents (protocols, CSRs, ICFs, CTDs, manuscripts, etc.). Perform quality control for accuracy, consistency, and compliance with industry standards. Review statistical analysis plans, tables, and figures for clarity and correctness. Collaborate with cross-functional teams (data management, biostatistics, project management) to ensure timely and high-quality deliverables. Communicate with sponsors to manage document expectations and negotiate changes. Mentor and support junior and senior medical writers; act as backup when needed. Contribute to project coordination and assist other Medical Affairs team members as required. Requirements Master degree in life sciences or equivalent. A relative experience of a minimum of 3 years in medical writing. Has previous experience working a CRO. Analytical skills and ability to interpret data. A strong work ethic. Intellectual curiosity and creativity. The ability to work effectively in a team in a fast-paced and dynamic environment. Advanced level of English. Strong knowledge of ICH regulations, and CONSORT, STROBE and PRISMA guidelines. Benefits By joining Excelya, you will be part of a team that values audacity, care, and energy. You will benefit from an environment that nurtures your potential and pushes boundaries, contributing fully to our shared mission. #J-18808-Ljbffr


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