Associate, Regulatory Business Capabilities

JOB RESPONSIBILITIES  

Associate Level 

• Investigates solutions to operations’ issues and develops or contributes to written materials that communicate solutions and/or options to relevant stakeholders resulting in appropriate decisions.   

• Execute user acceptance testing during system releases to ensure high quality of systems 

• Coordinate user testing and acceptance of information solutions prior to deployment. 

• Ensures that the company’s critical information and records stored within GRS–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. 

• Gather metrics and generate standard reports regarding usage or support of GRS systems 

• Update master data or other standard configuration data elements within GRS systems in accordance with standard operating procedures 

• Participate in system release activities 

QUALIFICATIONS / SKILLS

Education: 

Associate: 

• Bachelor's degree or equivalent work experience  

Experience:  

Associate:  

• Demonstrated, basic knowledge of Healthcare and/or 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 project management and organizational skills 

Technical Skills 

Associate: 

• Training or equivalent experience in current information management concepts and practices. 

• Knowledge of application system management and change control processes, application validation and implementation in a GxP environment  

• Knowledge of Healthcare and/or pharmaceutical metadata and standards  

• Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, Brio, MS Access) preferred. 

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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