Medical Writer – Functional Service Provider (FSP)

About the role

Parexel is seeking a Medical Writer to join a Functional Service Provider (FSP) program supporting a key sponsor. The role involves creating and coordinating clinical development documents such as trial reports, protocols, investigator brochures, biomarker reports, and submission packages. You will work closely with sponsor teams, ensuring accuracy, organization, and compliance throughout the documentation lifecycle.

Key responsibilities

• Set up and maintain clinical documents within the Electronic Document Management System (EDMS).
• Review document status and manage workflow activities in sponsor systems.
• Coordinate timelines, track deliverables, and support project teams.
• Prepare meeting materials, attend trial and submission meetings, and document actions.
• Draft sections of clinical documents, including tables, figures, and supporting content.
• Organize document review cycles and incorporate stakeholder feedback.
• Perform quality control checks and technical/formatting reviews for investigator brochures and related documents.
• Support final package preparation, publishing, and archiving.
• Maintain accurate records in line with sponsor SOPs.

Required profile

• Experience in medical writing, clinical documentation, or related clinical research activities.
• Strong organizational abilities with capacity to manage multiple document‑related tasks simultaneously.
• Attention to detail and commitment to high‑quality output.
• Ability to work collaboratively within sponsor and cross‑functional teams.

Required skills

• Proficiency with an Electronic Document Management System (EDMS).