Associate II, Medical Writing

• Preparation, review and finalization of clinical study protocols, CSRs or related clinical documents
• Write CTD M2 and other regulatory documents for submissions (e.g., IND/NDA/BLA/MAA)
• Write China subgroup analysis reports, China submission documents
• Write briefing books and other documents to support CDE/FDA meetings and write responses to regulatory agency queries
• Write safety narratives, plain language summaries, and other clinical, regulatory, and public disclosure documents.
• Collaboration 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
• Active participation on clinical study teams in the development of clinical study documents
• Ensure that all medical writing deliverables are prepared according to International Conference on Harmonisation (ICH) and other relevant regulatory guidelines
• Ensure documents are generated in accordance with agreed internal processes and standards (eg Pfizer Global Document Style Guide), are submission ready and appropriately stored in an agreed document management system
• Ensure that appropriate quality control (QC) checks are performed on CSRs, other regulatory documents and other medical writing deliverables, as required
• Provide thorough and critical review or peer QC support, of documents prepared by others, as needed
• Ensure own work processes are constantly improved to reflect lessons learned from previous experiences
• May participate in CRDC initiatives to increase efficiency and productivity

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