Documentation Specialist / Medical Writer

About the role

We are looking for a Documentation Specialist / Medical Writer to join Parexel’s clinical development teams in Czechia, Hungary, the United Kingdom or the Netherlands. In this role you will act as an embedded resource responsible for preparing, coordinating and finalising high‑quality clinical and regulatory documents that support the delivery of clinical research programmes.

Key responsibilities

• Develop and maintain clinical and regulatory documents such as Clinical Trial Reports, Protocols, protocol amendments, Investigator’s Brochures, biomarker reports and submission dossiers.
• Manage document lifecycles within the Electronic Document Management System (EDMS), including setup, workflow routing and approvals.
• Establish and communicate project timelines in collaboration with trial and project teams.
• Prepare for and facilitate project meetings, kick‑off sessions, results alignment meetings and submission meetings.
• Draft clinical documents with appropriate tables, figures and in‑text citations according to agreed templates.
• Coordinate review cycles, track comments and ensure compliance with quality standards throughout the document lifecycle.

Required profile

• Experience in creating and managing clinical or regulatory documentation for pharmaceutical or life‑science projects.
• Proven ability to work closely with cross‑functional project teams and to manage document timelines.
• Strong attention to detail and familiarity with quality‑control and compliance processes in clinical research.

Required skills

• Electronic Document Management System (EDMS) – document setup, workflow management and approval tracking.