Senior Associate CSR job opportunity at Pfizer.

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DatePosted 30+ Days Ago bot
Pfizer Senior Associate CSR
Experience: General
Pattern: full-time
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degreeAssociate
loacation Malaysia - Kuala Lumpur, Malaysia
loacation Malaysia - Kua..........Malaysia

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 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 submission package    Files the 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     Senior Associate (cumulative from above)   Serve as the subject matter expert for specific CSR coordination business areas, authoring and   maintaining   local   Clinical   And   Medical Controlled Document (CMCD) /   Standard Operating Procedure   ( SOP ) /QC checklists, and managing document and email templates   Act as the system business administrator and primary point of contact for related processes   Independently leads moderately complex CSR projects and process improvement initiatives, providing guidance and mentorship to newly appointed CSR Coordinators where appropriate   Facilitate cross-departmental collaboration to streamline workflows, build consensus, and implement optimized CSR processes, regularly taking informal leadership roles to drive group agreements and progress.    Ensure proper workload distribution by factoring in team capacity and capability, while managing personal time to meet   objectives   for departmental projects   Provide ongoing quality reviews and process improvement suggestions to the work group or project team, supporting continuous enhancement of CSR coordination practices   maintain compliance and uninterrupted operations   Build the bridge across internal and external stakeholders to share   CSR related   regulations   ( e.g.   International Council for   Harmonisation   of Technical Requirements for Pharmaceuticals for Human Use   ( ICH )   E3), and be the leading voice   of the team     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. Regulatory Affairs

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