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)
Job Summary
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 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.
The Senior Associate serves as the subject matter expert for specific CSR coordination business areas, independently leads moderately complex CSR projects and process improvement initiatives, and provides guidance and mentorship to newly appointed CSR Coordinators.
Matching Summary
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).
Skills & Requirements
Must-have
CSR lifecycle management
Regulatory reporting and submissions
Quality control of CSR components
Project management of CSR activities
Coordination in regulated environment
Knowledge of regulatory guidelines
Mentoring and leadership in CSR
Nice-to-have
Electronic submissions and publishing
Troubleshooting technical issues
Cross-departmental collaboration
Customer service experience
Fluency in English and Chinese
Key Requirements
Master's or bachelor's degree in biological, medical, pharmaceutical or life sciences