Senior Medical Writer H/F - 75

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

We are seeking a Senior Medical Writer to produce medical writing deliverables (both regulatory and medical communication documents).

Main Activities:

- Ensure compliance with sponsors' and Excelya's SOPs, guidelines, and relevant legislation.
- Stay updated on changes in industry standards, laws, and procedures.
- Conduct literature reviews aligned with project and sponsor requirements.
- Write, edit, and review a wide range of medical documents (protocols, CSRs, ICFs, CTDs, manuscripts, etc.).
- Perform quality control for accuracy, consistency, and compliance with industry standards.
- Review statistical analysis plans, tables, and figures for clarity and correctness.
- Collaborate with cross-functional teams (data management, biostatistics, project management) to ensure timely and high-quality deliverables.
- Communicate with sponsors to manage document expectations and negotiate changes.
- Mentor and support junior and senior medical writers; act as backup when needed.
- Contribute to project coordination and assist other Medical Affairs team members as required.