职位描述

职位描述： 工作职责：Organizational Relationship(s) including to whom the position reports (title):Reports to Associate Director IMCS LeadPosition PurposeSubmission Table and Workflow (STW) Project Coordinator role serves as the primary STW point of contact to some given Therapeutic Areas. This role works closely with virtual teams composed of project leads from different function lines to coordinate the preparation and submission of Global Aggregate Reports in compliance with governing SOPs and regulations.1.Project management for multiple reports simultaneously2.Coordinate contributions for final reports, and coordinate review and approval process with different function lines, including Safety, Clinical, Regulatory, Discovery, and etc.3.Perform QC and address issues in terms of data and format, for compiled report and standard table, figure and chart4.Contribute to continuous improvement activities based on understanding of aggregate reporting and expertise with the Pfizer corporate systemsPrimary Responsibilities?Monitors project timelines and ensures the different objects in adherence to required timeframes.?Support the preparation of clinical trial and safety data tables related to regulatory submission including, but not limited to, NDA PADER, IND AR, CTSUR and IIR Line Listing.?Plays a coordinator role representing STW in “Virtual Teams” aimed at ensuring optimum collaboration among different function lines to resolve any reporting issues.?Contribute to continuous improvement, offer suggestions for system and process improvements.?Assists colleagues within and outside SER and WRS to support ad hoc data queries in support of aggregate reports.?Ensures clear communication of project requirements to contributor groups?Promotes consistency and standards with internal processes and deliverables.?Supports Regulatory inspections and audits as appropriate.?Performs QC reviews according to relevant SOPs and job aides?May participate in system user acceptance testing (including script development and execution).?May represent STW deliverables on divisionalinternal task forces as a subject matter expert.任职资格：Technical Skill Requirements?Good understanding of medical and scientific terminology.?Knowledge of Safety reporting systems and technologies?Knowledge of regulatorysafety regulations and guidelines desired.?Project Management skill desiredQualifications (i.e., preferred education, experience, attributes)?Bachelor required, biological, medical, or pharmaceutical sciences education desired.?Experience in the pharmaceutical industry, or healthcare related field preferred.?Experience in drug safety, medical information, or clinical research preferred.?Strong written and oral skills required.?Attention to detail and exceptional organizational skills?Experience in clinical study operations or regulatory operations preferred?Experience in project management preferred?Experience in electronic document management preferred?Experience in multinational company preferred 职能类别： 生物工程/生物制药

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