Associate CSR
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Job Location:
Makati City - Philippines
Monthly Salary:
Not Disclosed
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
This team ensures PfizersClinical 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 Pfizers global drug registration and approval processes including submission publishing and archiving of related reports and documents.
Associate
Lead the coordinationcompilation quality controlapprovaland post-approval processes associated with development of Pfizer global CSRs
Create CSRmockupsin System and populate document templates
Project manage CSR compilationapprovaland 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 standardsubmission-readyandregulatorycompliant packageandcontributes to submissionpackage
Files thereport toTrial Master Files(TMF)systemto 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
Preferably can speak Mandarin
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 AffairsRequired Experience:
IC
Key Skills
- CCTV
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- Analysis
- Higher Education
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- Jboss
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