Job Summary

Location: Warsaw, MZ, Poland

CSR Appendices Coordinator – responsible for authoring and managing Clinical Study Report (CSR) Appendices and clinical and regulatory references using regulatory information management systems (RIMS).

Job Responsibilities

• Defines scope of CSR Appendices with document authors and coordinates activities for detailed quality reviews.
• Imports, routes, and tracks documents in RIMS and confirms completeness of supporting documents such as casebooks and literature references.
• Maintains strong knowledge of CSR, CSR Appendices, CTD structure, and regulatory references.
• Effectively communicates deliverables to stakeholders, demonstrating interpersonal and organizational communication skills, including conflict management.
• Manages multiple tasks within overlapping timeframes, building positive relationships to enable high‑quality documents completed on time.

Qualifications

Experience and knowledge of clinical study reports, regulatory references, and CTD structure; strong communication and conflict management skills; ability to work independently and manage multiple priorities.

EEO and ADA Statement

Syneos Health is an equal opportunity employer. Candidates with disabilities are encouraged to request reasonable accommodations. The company complies with the Americans with Disabilities Act and the EU Equality Directive.