Freelance Principal Medical Writer

About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsabilities :

• Ensure full compliance with internal and external SOPs, industry guidelines, and applicable legislation.
• Conduct literature reviews as required by project specifications.
• Write, edit, and deliver a range of medical and clinical documents (protocols, CSR, CTD submissions, ICFs, IBs, manuscripts, posters, etc.).
• Review and perform quality control on medical writing deliverables for data accuracy, formatting, and regulatory compliance.
• Review statistical documents (SAPs, tables, listings) for clarity, format, and consistency.
• Maintain up-to-date knowledge of medical writing standards, regulations, and best practices.
• Collaborate cross-functionally with internal teams (data management, biostats, project management) to ensure quality and timely delivery.
• Act as a mentor and provide guidance to junior and senior medical writers on complex projects.
• Identify and escalate project quality issues to management as appropriate.
• Support project management and financial offer preparation for medical writing activities.

Participate in drafting and reviewing internal SOPs and training documents related to medical writing. Education: University degree in Life Sciences or equivalent; postgraduate studies a plus. Experience: 5+ years in medical writing within a clinical or regulatory environment.

Skills & Knowledge:

• Strong analytical and data interpretation skills.
• Excellent attention to detail and commitment to quality.
• Advanced written and spoken English.
• In-depth understanding of ICH, CONSORT, STROBE, and PRISMA guidelines.
• Strong organizational, leadership, and mentoring abilities.
• Comfortable working in a fast-paced, team-oriented, and deadline-driven setting.
• High ethical standards, intellectual curiosity, and creativity.

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