Senior Medical Writer

About the role

ProductLife Group seeks an experienced Senior Medical Writer to lead the preparation and review of safety and regulatory documents within its Hub. The role involves interpreting clinical data, ensuring compliance with French and European guidelines, and delivering high‑quality medical writing outputs for internal and client projects.

Key responsibilities

• Analyse data and produce ad‑hoc reports such as PADER, risk‑management plans, benefit‑risk evaluations, signal detection reports, PSUR/PBRER, DSUR, and off‑label use reports.
• Screen literature and incorporate findings into medical writing deliverables.
• Review and validate safety reports, ensuring adherence to GVP, ICH and client SOPs.
• Provide medical training to cross‑functional staff and draft quality documents (SOPs, working practice documents).
• Interpret clinical and scientific reports to accurately capture safety and efficacy data.
• Prepare aggregate report plans, coordinate with QPPV and clients, and support audit/inspection activities.
• Assist in CAPA proposals, technical agreement reviews, effort estimation for RFPs, and bid defence meetings.

Required profile

• Extensive experience in medical writing and pharmacovigilance reporting.
• Strong knowledge of French and European GVP, ICH guidelines, and regulatory requirements.
• Proven ability to analyse clinical evidence and produce clear, balanced scientific narratives.
• Excellent client communication skills and experience participating in audits and inspections.

Required skills

What we offer

• Opportunity to work within a dynamic, multidisciplinary team.
• Exposure to a wide range of therapeutic areas and regulatory projects.
• Professional development and training in medical writing and safety reporting.