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 su bmission package
- Files t he 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
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.
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What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Hybrid Workspace
Employees engage in a combination of remote and on-site work.
