Medical Writer – FSP (Client Aligned)

About the role

We are expanding our Medical Writing FSP team in Europe and need a dedicated Medical Writer to support a client in the functional service provider space. The role involves creating high‑quality clinical and regulatory documents that meet stringent regulatory standards.

Key responsibilities

• Write and edit clinical study reports, protocols, investigator brochures and regulatory submission dossiers.
• Collaborate with cross‑functional teams to gather data and ensure document accuracy and completeness.
• Ensure all deliverables comply with regulatory guidelines, company standards and industry best practices.
• Manage project timelines, track deliverables and meet agreed‑upon deadlines.
• Stay up‑to‑date with evolving regulatory requirements and industry trends.

Required profile

• Bachelor’s degree in a scientific discipline (advanced degree preferred).
• Minimum 3 years of regulatory/medical writing experience in the pharmaceutical or CRO environment.
• Experience with EU Clinical Trials Regulation (CTR) is a plus.
• Strong organizational, program‑management and communication skills.
• Self‑motivated, adaptable and capable of independent decision‑making.

Required skills

• Structured Content Authoring systems.
• Automation tools for document production.
• In‑depth knowledge of regulatory guidelines and drug‑development processes.

What we offer

• Opportunity to work within a global leader in clinical research services.
• Collaborative team environment with focus on professional development.
• Access to resources that support career growth and scientific impact.