This team ensures Pfizer'sClinical Study Report(CSR)managementmeetsglobal agency standards and manages regulatory reporting, dossier development, and submission activities for Global Regulatory & International Operations (RIO).Members in the teamoverseeandmanageend-to-end lifecycledevelopmentof CSRto support Pfizer's global drug registration and approval processes, including submission, publishing, and archiving of related reports and documents.

• Lead the coordination,compilation, quality control,approvaland post-approval processes associated with development of Pfizer global CSRs

• Create CSR mockups in System and populate document templates

• Project manage CSR compilation,approvaland publishing activities

• Execute submission readyQuality Control (QC)on CSR components and structure

• Communicate with function linesregardingissues with CSR components and seek resolutions

• Seek approval from signatories onfinalizedCSRs 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 studyPrincipal Investigators(PIs)

• CoordinatePublic Disclosure Synopsis(PDS)andPlain 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 meetregulatory 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 andmaintaininglocalClinicalAndMedical 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 meetobjectivesfor 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 shareCSR relatedregulations(e.g.International Council forHarmonisationof Technical Requirements for Pharmaceuticals for Human Use(ICH)E3), and be the leading voiceof the team

Skill Requirements:

• In-depth knowledge of drug development process
• Independent delivery of all phases CSR for all Theraputic Areas (TAs) and advanced CSRs
• Great CSR timeline management capability and decent CSR coordination communication skills
• Demonstrated coordination of activities in a highly regulated environment and mastery of concurrent task management
• Demonstrate an understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regulatory dossiers
• In depth knowledge of regulatory guidance, data standards, and practices pertaining to technological aspects of submission management and publishing
• Experience of successfully mentoring others
• Demonstration of experience working in a customer service environment
• Preferred skills in electronic submissions builds and/or publishing within the Pharmaceutical Industry
• Preferred ability to troubleshoot independently and resolve technical issues efficiently

QUALIFICATIONS

• Master's or bachelor's degree in biological, medical, pharmaceutical sciences or life sciences preferred
• Proficiency in English and Chinese language preferred (read, written and spoken)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs