Senior Medical Writer - Remote Regulatory Docs

Parexel; Poland; Remote; PLN 258,000 - 388,000; Full time

Job summary

Parexel is seeking a Senior Medical Writer to support the development of high-quality clinical and regulatory documents. This embedded role involves coordinating CTRs, CTPs, IBs, and submission documents, while managing timelines and ensuring quality and compliance across the document lifecycle.

You will work with cross-functional teams to prepare, review, and publish key study documents, contributing to regulatory submissions and the advancement of new therapies for patients.

Qualifications

• Bachelor’s degree or equivalent in life sciences or related field.
• Strong medical writing and document management experience.
• Experience coordinating cross-functional teams in regulated environments.

Responsibilities

• Develop and maintain clinical and regulatory documents (CTRs, CTPs, IBs).
• Manage documents within EDMS, including setup, workflow, and approvals.
• Establish and track project timelines with trial teams.
• Prepare and document meetings; drive review cycles and approvals.
• Draft documents with tables and figures per procedures.
• Coordinate reviews, consolidate comments, and archive final versions.
• Support quality control and publishing activities for submissions.
• Ensure compliance with procedures and SOPs across teams.

Skills

Medical writing

Project coordination

Document management

Stakeholder communication

Education

Bachelor's degree

Life sciences background

Tools

EDMS

MS Office

Submission workflow tools

Job description

Parexel is seeking a Senior Medical Writer to support the development of high-quality clinical and regulatory documents. This embedded role involves coordinating CTRs, CTPs, IBs, and submission documents, while managing timelines and ensuring quality and compliance across the document lifecycle.

You will work with cross-functional teams to prepare, review, and publish key study documents, contributing to regulatory submissions and the advancement of new therapies for patients.