CSR Document Specialist

IQVIA

. Coordinate the development, compilation, review, and finalization of Clinical Study Report appendices .

Posted 9/24/2026full-timeWarsaw • PolandJuniorMid-Level💰 PLN 171,500 - PLN 318,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical document management, regulatory compliance, and quality control processes, with a strong focus on supporting Clinical Study Reports and regulatory submissions. Proficient in maintaining document integrity and optimizing workflows within electronic document management systems.

Highest-signal resume keywords

Clinical Document ManagementRegulatory SubmissionsICH E3 GuidelinesGood Clinical Practice (GCP)Electronic Document Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Report DevelopmentQuality Control ChecksVersion ControlDocument FormattingFinancial Disclosure Module Development

Soft Skills

Project CoordinationRisk MonitoringProcess Optimization

Tools & Technologies

Veeva VaultDocumentumSharePoint

Industry Keywords

Life SciencesPharmaceuticalBiotechnologyCROSOP Compliance

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Coordinate the development, compilation, review, and finalization of Clinical Study Report appendices
Lead CSR appendices kickoff meetings and define timelines with the CSR sub-team
Format CSR appendices according to templates, style guides, and regulatory requirements
Develop the Financial Disclosure and BIMO module for submission studies as required
Maintain version control throughout the document lifecycle
Perform quality control checks on CSR appendices
Ensure compliance with SOPs, ICH guidelines, and submission standards
Support document review workflows, approval processes, and submission-ready publishing
Coordinate document development, review, and approval timelines
Monitor project milestones and escalate delivery risks
Support inspection and audit readiness activities
Maintain document repositories and archival records in electronic document management systems
Follow data integrity and confidentiality requirements
Improve TMF document processes and contribute to process optimization initiatives

Requirements

What you’ll need

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
Familiarity with ICH E3 Clinical Study Report guidelines
Knowledge of Good Clinical Practice (GCP) requirements
Experience with electronic document management systems (Veeva Vault, Documentum, SharePoint, or similar)
Experience supporting regulatory submissions and publishing activities

Benefits

Comp & perks

Health and welfare benefits may be offered
Incentive plans, bonuses, and/or other forms of compensation may be offered