职位描述

职位描述： Position Purpose:Individuals filling the position listed are responsible for providing subject matter expertise in the management of the regulatory information management applications as well as associated change management and support activities for the Information Management, Operations Center of Excellence Regulatory Solutions system portfolio. Incumbent will partner with Business Technology and business lines to ensure timely support for systems, help ensure data integrity and compliance.Primary Responsibility:?Supports integration of regulatory solutions into business processes?Investigates solutions to customer issues and develops or contributes to written materials that communicate solutions and/or options to relevant stakeholders resulting in appropriate decisions.?Liaise with regulatory business including - safety, regulatory, operations and technical groups to define or gather business requirements, define new business and support processes or improve existing processes.?Liaise with business and technical groups to provide/review impact assessments of business requirements and technical change which include the identification of processes and applications, required changes to these processes and applications, and alternatives to mitigate impact.?Support continuous improvement projects to simplify and improve system use and system management.?Develop and execute ad hoc or standard queries to extract data from supported systems and follow established procedures to validate queries/results in support of business requirements?Gather metrics and generate standard reports regarding usage or support of IM systems?Update master data or other standard configuration data elements within IM systems in accordance with standard operating procedures?Participate in and may lead system release activities including: release readiness, testing, coordination and communication.?Contribute as appropriate to overall training program for regulatory solutions and collaborate with business lines to ensure a consistent approach with business process-specific training.?Participate in development of solution test strategies and author/execute user acceptance testing during system releases to ensure high quality of Regulatory systems?Participate in and lead small quality oriented projects intended to ensure high quality data in our regulatory tracking systems?Provide data analysis support ongoing to key stakeholders for regulatory data?Ensures that the company’s critical information and records stored within COE–owned repositories are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that content is available for critical business needs and is retained in accordance with established retention schedules.?Participate in and may lead small projects of short duration, following established methodologiesQualification:?Bachelor’s Degree in life sciences, information management, library science, information technology, computer science, business administration or related discipline required, masters degree preferred.?Demonstrated, in depth knowledge of Pharmaceutical drug development environment and regulations.?Demonstrated customer relationship skills and capabilities and collaboration on teams.?Demonstrated ability to perform in a cross-functional environment.?Strong verbal, written communication and presentation skills.?Ability to interact in a professional manner and build strong collaborative relationships with internal Pfizer teams.?Ability to interface with international colleagues, understand the “big picture” in terms of potential implications of changes to systems and processes to sites and/or affiliates outside of home country/region?Strong demonstrated project management and organizational skills?Strong verbal, written communication and presentation skills. 职能类别： 临床数据分析员

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