Senior Principal Medical Writer: Regulatory Submissions Lead

3015 Syneos Health Poland sp. z o.o.; Polska; Hybrid; PLN 180,000 - 280,000; Full time

Job summary

Syneos Health Poland sp. z o.o. seeks a Sponsor Dedicated - Sr. Principal Medical Writer to lead regulatory submission documents including ISE/ISS/Clinical Overview. You will manage cross-functional teams and mentor junior staff in a globally regulated environment.

The role emphasizes oncology experience, advanced regulatory knowledge, and strong project management in a CRO setting. On-site Poland location with global collaboration opportunities.

Qualifications

• Minimum five years of medical writing experience in biopharmaceutical/CRO industry or similar clinical/preclinical development.
• Strong ability to organize and communicate clinical information with minimal supervision.
• Excellent written and verbal communication skills; capable of working in a cross-functional team.

Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally in line with ICH guidelines and client standards.
• Manage medical writing projects, including timelines and cross-functional coordination.
• Review related project documents (Protocol, SAP) and contribute to process improvements.

Job description

Syneos Health Poland sp. z o.o. seeks a Sponsor Dedicated - Sr. Principal Medical Writer to lead regulatory submission documents including ISE/ISS/Clinical Overview. You will manage cross-functional teams and mentor junior staff in a globally regulated environment.

The role emphasizes oncology experience, advanced regulatory knowledge, and strong project management in a CRO setting. On-site Poland location with global collaboration opportunities.