Clinical Writer — Medical Device Evidence & Strategy

Talents Solutions; Lyon; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Restaurant vouchers

Eco-friendly transport allowance

Job summary

Talents Solutions is seeking an experienced Clinical Writer to lead the creation of high-quality clinical documentation and participate in product development. You will shape clinical strategies, ensure scientific excellence across the portfolio, and collaborate with regulatory teams to address Notified Bodies and authorities.

The role requires extensive experience in medical device regulatory standards, advanced English writing skills, and a strong background in clinical research to drive

Qualifications

• Solid knowledge of statistical methods applied to clinical data analysis
• Clear and concise writing style 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 Regulation 2017/745, and associated MDCG guidance
• Advanced English proficiency (C1 level) for technical and professional writing
• Bachelor's degree or higher in a scientific field; specialization in clinical research is valued
• Minimum 5 years of significant experience in a similar clinical role

Responsibilities

• 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
• Participate in developing clinical evaluation strategies
• Independently author clinical evaluation plans and reports with critical analysis of clinical data
• Independently author PMCF (Post-Market Clinical Follow-up) plans and evaluation reports
• Participate in product risk management
• Collaborate with the regulatory team to draft responses to clinical questions from Notified Bodies and Regulatory Authorities
• Ensure consistency, scientific quality, and regulatory compliance of all documentation
• Ensure comprehensive and rigorous evaluation of clinical data
• Collaborate with regulatory affairs to prepare responses to clinical questions
• Support responses to Notified Bodies and Regulatory Authority inquiries
• Maintain consistency and scientific quality across all clinical documentation
• Guarantee regulatory compliance according to internal procedures and regulatory requirements
• Support product risk management from a clinical perspective

Skills

Statistical analysis

Clinical writing

Regulatory knowledge

Regulatory standards

Education

Bachelor's degree in science

Clinical research specialization

Job description

Talents Solutions is seeking an experienced Clinical Writer to lead the creation of high-quality clinical documentation and participate in product development. You will shape clinical strategies, ensure scientific excellence across the portfolio, and collaborate with regulatory teams to address Notified Bodies and authorities.

The role requires extensive experience in medical device regulatory standards, advanced English writing skills, and a strong background in clinical research to drive