Document Specialist

• 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

Document Specialist jobs in Poland

CSR Document Specialist