CSR Document Specialist

IQVIA · Warsaw, Poland +3 more

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Role summary

IQVIA seeks a Clinical Study Report Document Specialist to coordinate, format, and ensure quality control of clinical documentation across multiple European locations. This role manages CSR appendices throughout their lifecycle while maintaining compliance with regulatory standards and supporting submission-ready deliverables.

What they're looking for

Bachelor's degree in Life Sciences, Pharmacy, Nursing, Health Sciences, Biotechnology, or related field
2–5 years experience in clinical document management or regulatory operations
Experience supporting Clinical Study Reports and regulatory documentation
Familiarity with ICH E3 Clinical Study Report guidelines and GCP requirements
Proficiency with electronic document management systems (Veeva Vault, Documentum, SharePoint)

What you'll be doing

Coordinate development, compilation, review, and finalization of CSR appendices for assigned studies
Format documentation according to templates, style guides, and regulatory requirements; maintain version control
Perform quality control checks to ensure compliance with SOPs, ICH guidelines, and submission standards
Manage project timelines, coordinate review cycles, monitor milestones, and escalate delivery risks
Support audit readiness activities and maintain document repositories within electronic management systems

Compensation171,500 zł - 318,500 zł base annual salary

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Date posted4 days ago

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