Medical Writer in the pharmaceutical industry (M/F)
Reporting to the Head of the Clinical Evaluation and Medical Writing Department, your main mission will be to draft the constituent elements of clinical evaluation dossiers for implantable medical devices (class IIb and III) in order to obtain or maintain CE marking. More specifically, you will: Ensure the performance of Clinical Evaluation for medical devices in the field of general orthopedics (Class IIb and III):
- Draft the clinical evaluation plan,
- Be responsible for literature research in international databases, including the search and selection of relevant documents.
- Compile relevant information into a state of the art of the pathology concerned, therapeutic alternatives, and gold standard treatments.
- Summarize and perform critical analysis of relevant clinical data.
- Integrate internal clinical data.
- Analyze and synthesize all clinical data (internal and publications) to determine performance, benefit, safety, and the acceptability of the benefit/risk ratio and validate compliance with MEDDEV.
- Compile clinical evidence into a clinical evaluation report in accordance with the clinical evaluation plan.
- Ensure scientific monitoring according to the associated procedure:
- Implement an automatic alert procedure with relevant keywords
- Select and record relevant articles
- Draft a summary document
- Ensure the organization and maintenance of the internal bibliographic database
- Also draft post-market clinical follow-up plans in accordance with the conclusions of the report and the risk analysis.
- Participate in the performance of product risk analyses according to ISO 14971
Your profile: Possessing higher scientific education (MSc, Engineer, etc.) ideally completed by a specialization in clinical evaluation or, you have 2-3 years of experience in drafting clinical evaluation reports according to MEDDEV 2.7/1 rev4 or the European Medical Device Regulation 2017/745. You are recognized for your clear, concise writing style with a high level of attention to detail. You possess the ability to understand, analyze, and interpret complex clinical data and a strong ability to synthesize, and you enjoy working in a team. You demonstrate an ability to work in a demanding environment with tight deadlines and to perform multiple tasks. Proficiency in operational written English is indispensable. Daily essentials
- Company health insurance
- Meal vouchers and connected fridges
- Participation and Company Value Plan (PVE)
- Concierge service
*To learn more about this opportunity, we invite you to meet us at the LNVDS Forum on September 22, 2026, from 9:30 am to 4:00 pm in the Saint-Exupéry room, located at 155 rue des Écoles, 69730 GENAY. Access via the "Genay Lavoir" bus stop 43. Come in large numbers to discover our offers and exchange directly with the recruiters.*