• • 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 Medical #LI-PFE