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Medical Writer (W/M)

Offre publiée le vendredi 14 janvier 2022

Company activity: CRO specialized in clinical trials and bioanalysis, with strong experience in the microbiome field.

Team: Scientific & Technical Support

 

Context

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)

 

Responsibilities

  • 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.

 

Profile

. 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

 

Useful information

Office is located at 3 route de la Chatterie, 44800 Saint Herblain – France

Several days per week of home office accepted

Partial time possible

 

 

 

Offre publiée le vendredi 14 janvier 2022
Offre publiée le vendredi 14 janvier 2022
Offre publiée le vendredi 14 janvier 2022
Offre publiée le vendredi 14 janvier 2022
Offre publiée le vendredi 14 janvier 2022

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