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 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.
The Senior Associate serves as the subject matter expert for specific CSR coordination business areas, independently leads moderately complex CSR projects, and facilitates cross-departmental collaboration to streamline workflows and drive group agreements.
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
Clinical Study Report lifecycle management
Regulatory reporting and dossier development
Quality control of CSR components
Project management of CSR activities
Coordination in highly regulated environment
Regulatory submission and publishing
Cross-departmental collaboration
Nice-to-have
Mentoring and guidance skills
Customer service experience
Troubleshooting technical issues
Fluency in English and Chinese
Process improvement initiatives
Key Requirements
Master's or bachelor's degree in biological, medical, pharmaceutical or life sciences
Proficiency in English and Chinese language preferred
In-depth knowledge of drug development process
Experience in regulatory guidelines and dossier filing
Experience mentoring others
Experience in pharmaceutical electronic submissions and publishing