Information Manager Regulatory Solutions (Remote)

• 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, 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.
• Individual filling the position is responsible for leading midsize projects to elicit business requirements for our regulatory systems and taking those requirements through the software development lifecycle in partnership with Digital.

• This role will directly report to Shanghai – Sr. Manager, Regulatory Solutions, Information Management

• 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 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 application issues and develop or contribute to written materials that communicate solutions and/or options to relevant stakeholders
• Provide data analysis support ongoing to key stakeholders for regulatory data
• 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 automation and system integrations
• Ensures regulatory systems are fully compliant and inspection ready.
• Influences the external environment through participation in industry working groups.

• 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 role or 5+ years in pharmaceutical industry
• Strong business analytical and critical thinker with the ability to solve issues and communicate findings
• 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.
• Good working knowledge of MS Office Programs – Excel, PowerPoint, Word and Outlook
• Experience with data analysis, reporting, automation techniques and technologies (e.g., SQL, PL/SQL, Spotfire, Alteryx, Python, VBA, MS PowerAutomate/PowerApps) a plus

• Master’s Degree in life sciences, information management, library science, information technology, computer science, business administration or related discipline
• 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

Information & Business Tech

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