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 clini...