• • 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

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