Medical Writer

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.

Main Responsibilities

The expected Services will include:

• Draft or review regulatory documents with comments (Integrated Summary of Safety, Integrated Summary of Efficacy, Summary of Clinical Efficacy, Summary of Clinical Pharmacokinetics, Summary of Clinical Safety, Clinical Overview).
• Prepare Briefing Documents for FDA meetings (Clinical Type C Meetings).
• Write scientific publications.
• Ensure quality control of documents.
• Review and analyze clinical documents and scientific publications.
• Contribute to the development of operational plans (Statistical Analysis Plan, Statistical Validation Plan).
• Participate in team meetings and collaborative work related to editorial strategy.
• Conduct scientific and regulatory monitoring of medical writing activities.
• Assess and recommend standards and processes for medical writing.
• Draft and update documents, incorporating reviewer comments.

About You

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

• Experience: Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years— talent matters most to us!).
• Skills: Strong writing skills in clinical documents (Protocol, Clinical Study Report, Clinical Summary, Clinical Overview).
• Education: Qualifications in a Clinical Writing Role.