Senior Associate CSR

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 Investigator s ( 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

Senior Associate (cumulative from above)

• Serve as the subject matter expert for specific CSR coordination business areas, authoring and maintaining local Clinical And Medical Controlled Document (CMCD) / Standard Operating Procedure ( SOP ) /QC checklists, and managing document and email templates

• Act as the system business administrator and primary point of contact for related processes

• Independently leads moderately complex CSR projects and process improvement initiatives, providing guidance and mentorship to newly appointed CSR Coordinators where appropriate

• Facilitate cross-departmental collaboration to streamline workflows, build consensus, and implement optimized CSR processes, regularly taking informal leadership roles to drive group agreements and progress.

• Ensure proper workload distribution by factoring in team capacity and capability, while managing personal time to meet objectives for departmental projects

• Provide ongoing quality reviews and process improvement suggestions to the work group or project team, supporting continuous enhancement of CSR coordination practices

• maintain compliance and uninterrupted operations

• Build the bridge across internal and external stakeholders to share CSR related regulations ( e.g. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ( ICH ) E3), and be the leading voice of the team

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