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 signa...