- Compile, format, and publish Clinical Study Reports (CSRs) and appendices in line with ICH E3 guidance and sponsor requirements.
- Prepare submission-ready PDFs with bookmarks, hyperlinks, cross-references, navigation tools, and tables of contents.
- Assemble supporting documentation from multiple teams and external vendors.
- Perform document-level QC reviews covering formatting, pagination, links, cross-references, tables, figures, listings, and completeness.
- Redact clinical and regulatory documents for ClinicalTrials.gov, CTIS, EudraCT, and other disclosure activities.
- Review redacted documents and remove confidential commercial information and personal data according to applicable regulations and sponsor guidance.
- Support electronic submission packages, document lifecycle management, version control, and archiving.
- Maintain publishing standards, templates, and document management processes, and contribute to inspection and audit readiness.
- Collaborate with Medical Writing, Regulatory Affairs, Biostatistics & Programming, Clinical Data Management, Pharmacovigilance, Project Management, and Quality teams.
- Share best practices, support process improvements, and stay current with regulatory guidelines.
GCP