CSR Document Specialist (Clinical Research)

Location: Warsaw, Poland

Salary: 171,500–318,500 PLN annually

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Coordinate the development, compilation, review, and finalization of Clinical Study Report appendices.
• Lead kickoff meetings, define timelines, coordinate review cycles, and monitor project milestones.
• Format CSR appendices according to templates, style guides, ICH guidelines, SOPs, and regulatory requirements.
• Develop Financial Disclosure and BIMO modules for submission studies when required.
• Perform quality control checks and verify submission-ready formatting and publishing requirements.
• Manage version control, electronic document repositories, archival records, inspection readiness, and process improvement initiatives.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Health Sciences, Biotechnology, Medical Communications, or a related discipline.
• 2–5 years of experience in clinical document management, medical writing support, regulatory operations, or pharmaceutical, biotechnology, or CRO environments.
• Experience supporting Clinical Study Reports and regulatory documentation.
• Knowledge of ICH E3 Clinical Study Report guidelines and Good Clinical Practice requirements.
• Experience with electronic document management systems such as Veeva Vault, Documentum, SharePoint, or similar tools.
• Role based in Warsaw, Poland.

Culture & Benefits

• Work on clinical documentation that supports regulatory submissions and the development of medical treatments.
• Collaborate with TMF Managers, Study Leads, Medical Writers, Biostatisticians, Clinical Operations, Regulatory Affairs, Data Management, and Quality teams.
• Support inspection and audit readiness in a regulated clinical research environment.
• Base pay may be supplemented by incentive plans, bonuses, health and welfare benefits, and other compensation depending on the position.