Senior Clinical Writer Remote Regulatory Documentation

Talents Solutions; Lyon; Sur place; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Restaurant vouchers

Eco-friendly transport allowance

Résumé du poste

Talents Solutions is seeking an experienced Clinical Writer to join our medical device team in Lyon, France. You will drive clinical documentation, develop evaluation strategies, and author PMCF plans and reports with rigorous analysis of clinical data.

The role requires advanced English, a scientific degree, and at least five years of clinical writing experience in regulated environments. Telework-friendly position with strong collaboration across regulatory and development teams.

Qualifications

• Statistical methods applied to clinical data analysis.
• Clear, concise writing with training in clinical literature research methodology.
• Deep knowledge of medical device regulations and standards (ISO 14971, GCP, ISO 14155, MEDDEV 2.7/1 rev4, EU 2017/745, MDCG guidance).
• Advanced English proficiency (C1) for technical writing.
• Bachelor's degree or higher in a scientific field; specialization in clinical research valued.
• Minimum 5 years of experience in a similar clinical role.

Responsabilités

• Participate in the development of new products and author clinical development plans.
• Lead clinical literature reviews and compile state-of-the-art evidence, therapeutic alternatives, and reference treatments.
• Develop clinical evaluation strategies and independently author CE plans and reports.
• Author PMCF plans and evaluation reports with critical analysis of clinical data.
• Collaborate with regulatory affairs to prepare responses to questions from Notified Bodies and Authorities.
• Maintain regulatory-compliant, high-quality clinical documentation across products.

Connaissances

Statistical methods

Clinical writing

Regulatory standards

English proficiency

Formation

Bachelor of Science or higher

Description du poste

Talents Solutions is seeking an experienced Clinical Writer to join our medical device team in Lyon, France. You will drive clinical documentation, develop evaluation strategies, and author PMCF plans and reports with rigorous analysis of clinical data.

The role requires advanced English, a scientific degree, and at least five years of clinical writing experience in regulated environments. Telework-friendly position with strong collaboration across regulatory and development teams.