- Works closely with clinical study team to establish strategy, timelines, and project management for the reporting of clinical study data
- Collaborates with clinical study team members to prepare clinical study/trial protocols
- Collaborates with clinical study team members to interpret study results and prepare Clinical Study Reports (CSRs) and related documents
- Works closely with biostatisticians and clinicians to ensure study analysis results and statistical interpretations are accurately and clearly reflected in the CSR
- Manages all aspects of CSR production and ensures timely project delivery
- Ensures final CSRs conform to ICH-E3 guidelines and the Pfizer Global Document Style Guide.
- Ensures ‘public disclosure’ related components of CSRs are finalized to enable timely release of results into the public domain
- Writes or helps write clinical and regulatory documents to enable global and China regulatory submissions (IND, CTA, NDA/BLA/MAA, briefing packages) in CTD format
- Writes other clinical and regulatory documents including but not limited to patient safety narratives, basic results/public disclosure synopses, development-China-specific documents such as SARs, progress reports, subgroup analysis CSRs, bridging reports, China study protocols and CSRs, and China submission documents
Work Location Assignment: On Premise
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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