-Prepares, edits, and finalizes CSRs or related documents
-Collaborates with biostatisticians and clinical colleagues to interpret study results and ensure timely and accurate integration of data presented in the statistical tables and listings and other information sources into the CSR
-Participates actively in clinical study teams in the development of clinical study documents
-Ensures that all medical writing deliverables conform to International Conference on Harmonisation (ICH) and other relevant regulatory guidelines
-Ensures documents are generated in accordance with agreed internal processes and standards (e.g. Pfizer Global Document Style Guide), are submission ready, and appropriately stored in agreed document management system
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-Ensures that appropriate quality control (QC) checks are performed on CSRs, other regulatory documents and other medical writing deliverables, as required
-Provides thorough and critical review or peer QC support of documents prepared by others, as needed
-Ensures own work processes are constantly improved to reflect lessons learned from previous experiences
-May participates in CRDC initiatives to increase efficiency and productivity
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical