As a Medical and Clinical Writer within the clinical department at Milvue, you will be responsible for drafting regulatory clinical documents for innovative medical devices based on artificial intelligence.

This role involves close collaboration with the algorithm development, clinical, regulatory affairs, and vigilance teams, under the direction of the Clinical Affairs Manager.

Why Milvue ?

By joining us, you’ll have the opportunity to work in a dynamic and innovative company, where each project has a direct impact on healthcare improvement and patient well-being. You’ll be part of a passionate team, committed to quality and excellence, in a stimulating work environment that promotes professional and personal development.

Key Responsibilities :

• Clinical and Regulatory Writing : Development of study protocols, clinical study reports, investigator brochures, clinical modules for submission dossiers, and responses to clinical queries from health authorities.

• Scientific Monitoring and Systematic Review : Defining research questions, selecting and critically analyzing scientific and clinical literature, writing syntheses and clinical evaluation reports.

• Scientific Valorization : Coordinating submissions of abstracts, writing articles, posters, summaries, and slides for scientific congresses.

• Scientific Documentation Management : Participating in the registration of studies and results on public databases, optimizing document standards, participating in internal and external audits.

Contract start date : As soon as possible.

• Education : Master’s degree (Bac +5) or higher in Biology, Medicine, or a related field. PhD is a valued asset.

• Experience : At least 2 years of experience in medical writing, ideally in the field of medical device field. Prior experience in clinical research is highly desired.

• Technical Skills :
  - Experience in writing clinical and scientific documents.
  - Knowledge of medical device regulations (MDR 2017/745).
  - Proficiency in written and spoken English.
  - Skills in critical analysis and systematic literature review .

• Soft Skills :
  - Commitment, thoroughness, curiosity, and critical thinking.
  - Ability to work in a team and across functions.
  - Excellent organizational, planning, and priority management skills.

2 interviews minimum with the Medical Director / Head of Clinical Affairs.