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

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