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Expertly delivering clinical trials operations, with care.
Senior Medical Writer – Lay Language
Location
France
Posted
32 days ago
Salary
0
Seniority
Senior
Job Description
Senior Medical Writer – Lay Language
Excelya
• Focus on drafting patient-facing clinical documents in lay language : • Drafting and revising (as needed): Lay summaries of Clinical Study Reports (CSR lay summaries), Protocol synopsis in lay language (Plain Language Protocol Synopsis) • Coordination of : authoring activities, document planning, review cycles with stakeholders • Maintaining scientific accuracy • Meeting EU CTR / CTIS plain-language expectations • Coordinating multi-stakeholder reviews within timelines • Ensuring robust quality control and version management • Content planning and outline proposal • Drafting from : CSR / protocol, supporting materials • Incorporation of review comments • Version management • Final document preparation • Contribution to : terminology consistency, glossary, readability
Job Requirements
- We are looking for a Senior Medical Writer with several years of clinical/regulatory writing experience
- Degree in Life Science, Pharmacy, Medicine, or a related scientific field
- Mandatory expertise: Lay-language writing, Health literacy principles, Patient-centric tone, Neutrality and accuracy,
- Respect confidentiality, data protection, access controls
- Experience with : EU CTR 536/2014, CTIS deliverables, Readability tools, Health literacy approaches
- Langages : Autonomous writing in English
Benefits
- At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
- 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.
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