Associate CSR

<p><span><span>This team ensures Pfizer&#39;s<span> </span></span><span>Clinical Study Report</span><span><span> </span></span><span>(CSR)<span> </span></span><span>management</span><span><span> </span></span><span>meets</span><span><span> </span>global agency standards and manages regulatory reporting, dossier development, and submission activities for Global Regulatory &amp; International Operations (RIO).<span> </span></span><span>Members in the team</span><span><span> </span></span><span>oversee</span><span><span> </span>and<span> </span></span><span>manage</span><span><span> </span>end-to-end lifecycle<span> </span></span><span>development</span><span><span> </span>of CSR</span><span><span> </span></span><span>to support Pfizer’s global drug registration and approval processes, including submission, publishing, and archiving of related reports and documents.</span></span><span> </span></p><p></p><p><b><span>Associate</span></b><span> </span></p><ul><li><p><span><span>Lead the coordination,<span> </span></span><span>compilation, quality control,<span> </span></span><span>approval</span><span><span> </span>and post-approval processes associated with development of Pfizer global CSRs </span></span><span> </span></p></li></ul><ul><li><p><span><span>Create CSR<span> </span></span><span>mockups</span><span><span> </span>in System and populate document templates</span></span><span> </span></p></li></ul><ul><li><p><span><span>Project manage CSR compilation,<span> </span></span><span>approval</span><span><span> </span>and publishing activities</span></span><span> </span></p></li></ul><ul><li><p><span><span>Execute submission ready<span> </span></span><span>Quality Control (</span><span>QC</span><span>)</span><span><span> </span>on CSR components and structure</span></span><span> </span></p></li></ul><ul><li><p><span><span>Communicate with function lines<span> </span></span><span>regarding</span><span><span> </span>issues with CSR components and seek resolutions</span></span><span> </span></p></li></ul><ul><li><p><span><span>Seek approval from signatories on<span> </span></span><span>finalized</span><span><span> </span>CSRs and update clinical trial registry with CSR milestone status</span></span><span> </span></p></li></ul><ul><li><p><span><span>Prepare investigators declaration packages for distribution to the coordinating investigator</span></span><span> </span></p></li></ul><ul><li><p><span><span>Prepare study data packages required for distribution to study</span><span><span> </span></span><span>Principal Investigator</span><span>s</span><span><span> </span></span><span>(</span><span>PIs</span><span>)</span></span><span> </span></p></li></ul><ul><li><p><span><span>Coordinate<span> </span></span><span>Public Disclosure Synopsis</span><span><span> </span>(</span><span>PDS</span><span>)</span><span><span> </span>and<span> </span></span><span>Plain Language Summary</span><span><span> </span>(</span><span>PLS</span><span>)</span><span><span> </span>activities</span></span><span> </span></p></li></ul><ul><li><p><span><span>Publishes the approved report into Pfizer standard<span> </span></span><span>submission-ready<span> </span></span><span>and</span><span><span> </span></span><span>regulatory<span> </span></span><span>compliant package</span><span>,</span><span><span> </span>and<span> </span></span><span>contributes to su</span><span>bmission<span> </span></span><span>package</span><span> </span></span><span> </span></p></li></ul><ul><li><p><span><span>Files t</span><span>he</span><span><span> </span>report to<span> </span></span><span>Trial Master Files<span> </span></span><span>(TMF)<span> </span></span><span>system</span><span><span> </span>to meet</span><span><span> </span>regulatory requirements</span></span><span> </span></p></li></ul><ul><li><p><span><span>Monitor public mailbox </span></span><span> </span></p></li></ul><p><span> </span></p><ul><li><p><span><span>Provide ongoing quality reviews and process improvement suggestions to the work group or project team, supporting continuous enhancement of CSR coordination practices</span></span><span> </span><span> </span></p></li><li><p><span>Preferably can speak Mandarin</span></p></li></ul><p>  <br />Work Location Assignment: Hybrid</p><p style="text-align:inherit"></p><p style="text-align:left"><span><span><span><span><span><span><span><span><span>Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</span></span></span></span></span></span></span></span></span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Regulatory Affairs<p></p><p></p>