Senior Medical Writer – Lay Language

This is a fully remote position, open to applicants in France.

📋 Description

• Concentrate on creating clinical documents for patients using accessible language.

• Crafting and updating (as necessary): Lay summaries for Clinical Study Reports (CSR lay summaries) and Protocol synopses in plain language (Plain Language Protocol Synopsis).

• Coordinating: authoring tasks, document planning, and review processes with various stakeholders.

• Ensuring scientific accuracy is maintained.

• Complying with EU CTR / CTIS requirements for plain-language documentation.

• Managing reviews from multiple stakeholders within established timelines.

• Guaranteeing thorough quality control and effective version management.

• Planning content and proposing outlines.

• Drafting based on: CSR / protocol and supporting materials.

• Integrating feedback from reviews.

• Managing document versions effectively.

• Preparing final documents.

• Contributing to terminology consistency, glossary development, and document readability.

⛳️ Requirements

• We seek a Senior Medical Writer with extensive experience in clinical and regulatory writing.

• A degree in Life Science, Pharmacy, Medicine, or a related scientific discipline is required.

• Essential skills include: writing in lay language, understanding health literacy principles, adopting a patient-centric tone, and ensuring neutrality and accuracy.

• Commitment to confidentiality, data protection, and access control is mandatory.

• Experience with: EU CTR 536/2014, CTIS deliverables, readability tools, and health literacy strategies is essential.

• Language proficiency: Ability to write autonomously in English.

🏝️ Benefits

• At Excelya, we merge our passion for science with a commitment to teamwork to redefine excellence in healthcare.

• We are a dynamic and ambitious health company, representing 900 Excelyates, striving to become Europe’s leading mid-sized CRO with the best employee experience.

• Our comprehensive service model, which includes full-service, functional service provision, and consulting, empowers you to grow through diverse projects.

• By collaborating with leading experts, you will enhance scientific, operational, and human knowledge, ultimately improving the patient experience.

• Excelling with care means thriving in an environment that appreciates your innate talents, encourages bold innovation, and fosters your potential, allowing you to fully engage in our collective mission.