Hybrid Medical Writer

at Excelya

• Job title: Medical Writer
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: No Education Requirement
• Location requirements: Hybrid, Genay, France

About the role

• Medical Writer creating impactful documentation for clinical studies and regulatory submissions. Collaborating with internal teams and ensuring clarity and compliance in scientific communications.

Responsibilities

• **Main Responsibilities:**
• Perform scientific literature surveillance in bibliographic databases, including search strategy development, publication selection, and critical analysis
• Compile relevant information into structured state-of-the-art sections covering the targeted pathology, therapeutic alternatives, and standard of care
• Contribute to CE marking submissions and renewals
• Draft and/or update Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), including critical appraisal of relevant clinical data in accordance with applicable guidelines
• Support Post-Market Clinical Follow-up activities (PMCF Plans and PMCF Reports)
• Collaborate closely with internal teams such as Regulatory Affairs and R&D/Engineering (clinical justifications to Notified Bodies, risk analyses, co-authoring of technical documentation)
• Contribute to the scientific valorization and dissemination of knowledge related to company products

Requirements

• **About You**
• We are looking for passionate professionals who are committed to delivering excellence and have a strong aptitude for scientific communication:
• **Education:** Degree in life sciences (MSc, Engineering degree, or equivalent), ideally complemented by specialization in clinical evaluation
• **Experience:** Experience in drafting Clinical Evaluation Reports under MEDDEV 2.7/1 rev.4 or EU Medical Device Regulation (EU MDR 2017/745)
• **Skills:** Strong understanding of clinical research processes and regulatory requirements.
• Excellent writing, editing, and organizational skills with meticulous attention to detail.
• Proficiency in Microsoft Office Suite and literature databases.
• **Languages:** Proficient in English (written and spoken); additional languages are a plus.

Benefits

• **Why Join Us? **
• At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
• Here's what makes us unique—
• We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's **leading mid-size CRO **with the **best employee experience**. Our **one-stop provider service model**—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
• **Excelling with care** means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.