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