*
* 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 documents0202
Work Location Assignment:02On 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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