Description

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. <ul><li>Lead the coordination, compilation, quality control, approval and post-approval processes associated with development of Pfizer global CSRs </li></ul><ul><li>Create CSR mockups in System and populate document templates </li></ul><ul><li>Project manage CSR compilation, approval and publishing activities </li></ul><ul><li>Execute submission ready Quality Control (QC) on CSR components and structure </li></ul><ul><li>Communicate with function lines regarding issues with CSR components and seek resolutions </li></ul><ul><li>Seek approval from signatories on finalized CSRs and update clinical trial registry with CSR milestone status </li></ul><ul><li>Prepare investigators declaration packages for distribution to the coordinating investigator </li></ul><ul><li>Prepare study data packages required for distribution to study Principal Investigators (PIs) </li></ul><ul><li>Coordinate Public Disclosure Synopsis (PDS) and Plain Language Summary (PLS) activities </li></ul><ul><li>Publishes the approved report into Pfizer standard submission-ready and regulatory compliant package, and contributes to submission package </li></ul><ul><li>Files the report to Trial Master Files (TMF) system to meet regulatory requirements </li></ul><ul><li>Monitor public mailbox </li></ul> <ul><li>Provide ongoing quality reviews and process improvement suggestions to the work group or project team, supporting continuous enhancement of CSR coordination practices </li></ul> Senior Associate (cumulative from above) <ul><li>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 </li></ul><ul><li>Act as the system business administrator and primary point of contact for related processes </li></ul><ul><li>Independently leads moderately complex CSR projects and process improvement initiatives, providing guidance and mentorship to newly appointed CSR Coordinators where appropriate </li></ul><ul><li>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. </li></ul><ul><li>Ensure proper workload distribution by factoring in team capacity and capability, while managing personal time to meet objectives for departmental projects </li></ul><ul><li>Provide ongoing quality reviews and process improvement suggestions to the work group or project team, supporting continuous enhancement of CSR coordination practices </li></ul><ul><li>maintain compliance and uninterrupted operations </li></ul><ul><li>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 </li></ul>Skill Requirements:<ul><li>In-depth knowledge of drug development process</li><li>Independent delivery of all phases CSR for all Theraputic Areas (TAs) and advanced CSRs</li><li>Great CSR timeline management capability and decent CSR coordination communication skills </li><li>Demonstrated coordination of activities in a highly regulated environment and mastery of concurrent task management</li><li>Demonstrate an understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regulatory dossiers</li><li>In depth knowledge of regulatory guidance, data standards, and practices pertaining to technological aspects of submission management and publishing</li><li>Experience of successfully mentoring others</li><li>Demonstration of experience working in a customer service environment</li><li>Preferred skills in electronic submissions builds and/or publishing within the Pharmaceutical Industry</li><li>Preferred ability to troubleshoot independently and resolve technical issues efficiently</li></ul>QUALIFICATIONS<ul><li> Master's or bachelor's degree in biological, medical, pharmaceutical sciences or life sciences preferred</li><li>Proficiency in English and Chinese language preferred (read, written and spoken)</li></ul>Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs

Senior Associate CSR

Description

Pfizer

Pipeline