Medical Writer (W/M)
Company activity: CRO specialized in clinical trials and bioanalysis, with strong experience in the microbiome field.
Team: Scientific & Technical Support
BIOFORTIS, a CRO specializing in clinical trials and bioanalysis, has been supporting innovation for its clients in nutrition, agri-food, biotech, pharma, academia and cosmetics for 20 years. With a staff of 90 collaborators, supported by Institut Mérieux, the team has more than 500 projects to its credit, 250 clinical trials managed full-service in France, Europe and internationally. In this context, Biofortis is looking for new talent to fill the position of Medical Writer (W/W)
- Intervene in the construction of the study designs of clinical trials.
- Compile, write and review rationale of clinical study protocols, clinical protocol amendments and clinical study reports in accordance with the current regulations.
- Be involved in the writing process of scientific papers, posters, literature reviews and customer presentations.
- Ensure the quality/accuracy of all information, data and references within the publications/documents produced.
- Work on a diversity of projects at the same time on different areas (nutrition, cardio-metabolism, weight management, …) and study populations.
- Work in close collaboration with customers, investigators, healthcare professionals and key opinion leaders as well as Project management, Biostatistics and Business Teams with a view to continuous improvement.
- Mentor and lead less experienced writers on complex projects, as necessary.
. Scientific degree: PharmD, PhD, Eng., MSc in biology, nutrition, pharmacy or medicine
. At least 5 years’ experience as a medical writer in clinical studies
. Native English or fluent level mandatory
. French: Basic/Intermediate level preferred
. Experience of writing and strong knowledge of ICH regulations, EFSA and CONSORT guidelines
. Team player with very good interpersonal skills that creates positive and productive working relationships
. Expertise in the nutrition filed (infant nutrition, functional food, novel food, etc.) would be highly appreciated
. Knowledge of the methodology underlying observational studies and for the clinical development of medical devices would be a plus
Office is located at 3 route de la Chatterie, 44800 Saint Herblain – France
Several days per week of home office accepted
Partial time possible