This team ensures Pfizer's Clinical Study Report (CSR) management meets global agency standards and manages regulatory reporting, dossier development, and submission activities for Global Regulatory & International Operations (RIO). Members in the team oversee and manage end-to-end lifecycle development of CSR to support Pfizer’s global drug registration and approval processes, including submission, publishing, and archiving of related reports and documents.
Associate
- Lead the coordination, compilation, quality control, approval and post-approval processes associated with development of Pfizer global CSRs
- Create CSR mockups in System and populate document templates
- Project manage CSR compilation, approval and publishing activities
- Execute submission ready Quality Control (QC) on CSR components and structure
- Communicate with function lines regarding issues with CSR components and seek resolutions
- Seek approval from signatories on finalized CSRs and update clinical trial registry with CSR milestone status
- Prepare investigators declaration packages for distribution to the coordinating investigator
- Prepare study data packages required for distribution to study Principal Investigators (PIs)
- Coordinate Public Disclosure Synopsis (PDS) and Plain Language Summary (PLS) activities
- Publishes the approved report into Pfizer standard submission-ready and regulatory compliant package, and contributes to submission package
- Files the report to Trial Master Files (TMF) system to meet regulatory requirements
- Monitor public mailbox
- Provide ongoing quality reviews and process improvement suggestions to the work group or project team, supporting continuous enhancement of CSR coordination practices
- Preferably can speak Mandarin
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
