• Write and edit clinical study reports, protocols, informed consent forms, and other clinical and regulatory documents including Investigator Brochures and annual reports.
• Assist with the preparation of briefing documents, INDs, and other major submissions (BLAs, MAAs) as needed.
• Lead the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts.
• Provide QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents).
• Review case report forms, statistical analysis plans, and data tables and listings for content and format.
• Participate in clinical project team meetings.
• Ensure the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards.