- Write and edit regulatory documents, including clinical trial protocols, amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and regulatory submission dossiers.
- Perform independent QC reviews of documents to verify accuracy and internal/external consistency against source materials.
- Review documents for adherence to style guides (e.g., AMA Manual of Style), templates, and regulatory guidance.
- Proofread and copyedit text to ensure clarity, grammar, and scientific/regulatory accuracy.
- Support the preparation and inspection-readiness of technical documents for global regulatory submissions, including integration of narratives, tables, and statistical output.
- Communicate QC findings constructively and collaborate with cross-functional stakeholders to resolve issues.
- Facilitate project management of document workflows from kickoff through publishing.
- Contribute to the continuous improvement of QC processes, checklists, and best practices.