Support the compilation of data from various sources, generate, and maintain dashboards, business scorecards, and reports.
Influence decision-making through data-driven insights and stakeholder engagement.
Investigate new technologies that enable better business efficiency, champion system changes, and adoption.
Work across all necessary stakeholders within and outside GRS to align business needs and expectations to technologies and long-term technology roadmaps.
Contribute to designing and building system user requirements, reviewing configuration specifications, and resolving system record investigations.
Contribute as a member of system change control boards and impact resolution teams and lead business discussions regarding specific projects and priorities.
Lead process development by translating business requirements into current and future business processes.
Keep informed of industry labeling/artwork trends and evaluate against and for Pfizer best practice.
Serve as the primary point of contact for label exchange activities under Pharmacovigilance Agreements.
Coordinate timely and compliant exchange of labeling information with external partners.
Monitor and resolve discrepancies, ensuring alignment with safety and regulatory commitments.
Lead labeling-related activities during acquisitions and divestitures, including due diligence and integration planning.
Act as the central liaison between internal teams and external stakeholders to ensure seamless transitions.
Develop and execute labeling strategies that support business continuity and compliance.
Maintain the integrity and accuracy of the labeling and artwork pan-portfolio intelligence data across applicable business and regulatory systems.
Ensure proper data governance, version control, and metadata management.
Coordinate the labeling universe maintenance process, including analysis and tracking of updates.
Ensure correct label tracking strategies are implemented in the setup of new products, updated during the lifecycle of the product and the correct end of label maintenance activities are performed.
May support one or more of the pan-portfolio labeling intelligence processes including but not limited to Pfizer Reference Label management across therapeutic areas; Maintenance of the Regulatory Requirements Database for international labeling; Single Reference Safety Document identification and management; Innovator Monitoring for the generic portfolio; North Star; Support audits and inspections by ensuring data readiness and traceability.
Provide strategic and operational support for high-impact, cross-portfolio initiatives.
Lead or contribute to special projects that enhance labeling processes, systems, or compliance.
Collaborate with global teams to drive innovation and continuous improvement.
Provide project management support across labeling initiatives, ensuring timelines, resources, and deliverables are met.
Requirements
Bachelor's Degree or equivalent with 8 + years relevant experience in global/multi-national pharmaceutical environment, including direct experience either in Labeling or Regulatory Affairs.
Experience with Business Analytics required.
Experience with interacting autonomously with leaders and working in a matrix team environment a must.
Experience in interpreting and applying global and local regulatory guidance around labeling/regulatory and associated supportive documentation desirable.
Ability to partner with wide range of business stakeholders, crossing multiple divisions across multiple countries/cultures
Proven leadership driving highly complex projects to meet evolving business needs
Ability to manipulate and understand complex data.
Mastery of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
Clear and adaptive verbal and written communication skills