* Individuals filling the position listed are responsible for providing subject matter expertise in the management of the regulatory information management applications, data integrity & reporting as well as associated change management and support activities for the Information Management, CD&O 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.
Organization Structure
* This role will directly report to Shanghai – Sr. Manager, Regulatory Solutions, Information Management
Primary Responsibilities
* Liaise with business and technical groups to define or gather business requirements, define new business and support processes or improve existing processes or data/reporting needs. * 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. * Participate in and lead large/medium quality oriented projects intended to ensure high quality data in our regulatory tracking systems * Conduct and coordinate impact assessments across systems for change requests * Provide solutions to customer data issues and develop or contribute to written materials that communicate solutions and/or options to relevant stakeholders * Develop and maintain suite of reporting solutions to serve the Regulatory organization and supporting business lines * Provide data analysis support ongoing to key stakeholders for regulatory data * 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 * Lead user acceptance testing during system releases to ensure high quality of Regulatory systems * Support continuous improvement projects to simplify and improve system use and system management, including opportunities for data automation and system integrations * Ensures regulatory systems are fully compliant and inspection ready. * Influences the external environment through participation and leadership in industry working groups.
Resources Managed (budget and FTEs)
* No direct reports - this role is an individual contributor role. Potential matrix management of cross-functional teams.
* Bachelor’s Degree in life sciences, information management, library science, information technology, computer science, business administration or related discipline or 5+ years’ experience in business analysis & data analysis role or 5+ years in pharmaceutical industry * Strong business analytical and critical thinker with the ability to solve issues and communicate findings * Experience with data analysis, reporting, automation techniques and technologies (e.g., SQL, PL/SQL, Spotfire, Alteryx, Python, VBA, MS PowerAutomate/PowerApps) * 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. * Strong demonstrated project management and organizational skills * Experience with systems management and maintenance including document management systems, databases, business process management and electronic workflow/routing tools, regulatory submission and tracking systems * Technical aptitude for learning new applications and data models * Ability to interact in a professional manner and build strong collaborative relationships with internal Pfizer teams. * Expert program management skills with experience in managing multiple concurrent, complex projects. * Good working knowledge of MS Office Programs – Excel, PowerPoint, Word and Outlook
PREFERRED QUALIFICATIONS
* Master’s Degree in life sciences, information management, library science, information technology, computer science, business administration or related discipline * Extensive experience in regulatory affairs, specifically with IDMP standards. * Proficiency in using Veeva systems for regulatory information management. * Understanding of the drug development process and regulatory interactions within the pharmaceutical industry
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
