Remote Medical Writer - Clinical & Regulatory Docs

Parexel; Poland; Remote; PLN 237,000 - 345,000; Full time

Job summary

Parexel is seeking a Documentation Specialist / Medical Writer to join a distributed team across Poland, Spain, Romania or Serbia. You will develop and finalize clinical and regulatory documents and manage document workflows within an electronic system, ensuring timely submissions and adherence to quality standards.

You will collaborate with cross-functional teams, coordinate review cycles, and support publishing and archival activities to drive successful study milestones in a fast-paced

Qualifications

• Experience with technical writing or medical writing in a regulated environment.
• Experience in clinical research or another regulated setting.
• Ability to collaborate across teams and communicate with stakeholders.
• Quality focus with strong attention to detail.
• Familiarity with EDMS and document review workflows.

Responsibilities

• Develop and maintain clinical and regulatory documents (CTRs, CTPs, IBs, submission documents).
• Manage documents within EDMS, including setup, workflows and approvals.
• Coordinate timelines with trial and project teams; support meetings and alignments.
• Draft documents with in-text tables and figures per procedures.
• Oversee quality control activities and document revisions.

Skills

Technical writing

Medical writing

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree

Tools

Electronic Document Management System (EDMS)

Job description

Parexel is seeking a Documentation Specialist / Medical Writer to join a distributed team across Poland, Spain, Romania or Serbia. You will develop and finalize clinical and regulatory documents and manage document workflows within an electronic system, ensuring timely submissions and adherence to quality standards.

You will collaborate with cross-functional teams, coordinate review cycles, and support publishing and archival activities to drive successful study milestones in a fast-paced