Medical Writer II - Regulatory & Clinical Docs (Remote)

Parexel; Poland; Remote; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Remote work option

Job summary

Parexel is seeking a Medical Writer II to join our team across Poland, Spain, Romania, or Serbia. You will support high-quality clinical and regulatory documents, including CTRs, CTPs, IBs, and submission materials, ensuring timely preparation and coordination.

You will work with cross-functional teams, manage document timelines, coordinate reviews, and support publishing and archiving in a fast-paced global environment.

Qualifications

• Minimum 1 year of experience as Medical Writer.
• Bachelor's degree or equivalent in a related field.
• Experience with clinical development documentation and regulated environments.
• Experience with EDMS and document lifecycle processes.
• Strong communication and organizational skills.

Responsibilities

• Develop and maintain clinical and regulatory documents such as CTRs, CTPs, IBs, and submission documents.
• Manage documents in EDMS, including setup, workflows and approvals.
• Plan and maintain project timelines with trial and project teams.
• Prepare and document meetings (kick-offs, Results Alignment, trial team, submission).
• Draft clinical documents with appropriate tables and figures.
• Coordinate review cycles, consolidate comments, record approvals.
• Oversee quality control activities and related documentation.
• Finalize and deliver documents to teams and support publishing and archiving.
• Perform technical and formatting checks for Investigator's Brochures and updates.
• Support electronic approvals and ensure SOP compliance.
• Collaborate within integrated team and participate in governance and alignment.

Skills

Medical writing

Project coordination

Document management

Regulated environment

Stakeholder communication

Attention to detail

EDMS familiarity

Education

Bachelor's degree

Tools

EDMS

Job description

Parexel is seeking a Medical Writer II to join our team across Poland, Spain, Romania, or Serbia. You will support high-quality clinical and regulatory documents, including CTRs, CTPs, IBs, and submission materials, ensuring timely preparation and coordination.

You will work with cross-functional teams, manage document timelines, coordinate reviews, and support publishing and archiving in a fast-paced global environment.