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Medical Digital Health Governance and Policies Lead – Secondment, 6 Months
Pfizer. Maintain deep, up-to-date expertise on global regulations, policies, and guidance related to digital health, AI, software as a medical device (SaMD), data use, and algorithm-enabled solutions .
About the role
Key responsibilities & impact- Maintain deep, up-to-date expertise on global regulations, policies, and guidance related to digital health, AI, software as a medical device (SaMD), data use, and algorithm-enabled solutions
- Monitor and assess emerging regulatory trends and policy developments, evaluating their potential impact on Pfizer’s digital health and AI strategy, portfolio, and operating model
- Translate complex regulatory and policy requirements into clear, practical guidance for internal stakeholders across Medical, Digital, Legal, Compliance, Regulatory, R&D, and Commercial
- Conduct impact assessments to identify regulatory risks, gaps, and dependencies across existing and planned digital health and AI initiatives
- Lead the design, development, and implementation of new or updated processes, SOPs, and governance frameworks to support compliant digital health and AI development
- Define and implement guardrails and control mechanisms that enable innovation while ensuring patient safety, data integrity, ethical use, and regulatory compliance
- Advise and support cross-functional teams throughout the end-to-end lifecycle of digital health and AI solutions, from ideation and development through deployment and lifecycle management
- Partner closely with Legal, Compliance, and Regulatory functions to ensure consistent interpretation and application of regulatory and policy requirements
- Support internal governance bodies and senior leadership by providing expert recommendations, risk assessments, and decision support related to digital health and AI innovation
- Contribute to continuous improvement of Pfizer’s digital health and AI governance model, balancing innovation velocity with risk management and compliance expectation
- Collaborate closely with stakeholders both internally and externally
Requirements
What you’ll need- MD + 5+ years required, PhD/PharmD + 7+ years required; MBA + 10+ years required
- Extensive experience in healthcare, life sciences, digital health, or AI-enabled solutions, with demonstrated focus on regulation, policy, and governance
- Deep understanding of digital health and AI regulatory frameworks, including SaMD, data governance, algorithm oversight, and emerging AI regulations
- Proven ability to interpret complex regulatory and policy requirements and translate them into practical, implementable processes and guidance
- Demonstrated experience designing and implementing processes, SOPs, or governance frameworks in regulated environments
- Strong matrix leadership skills, with the ability to influence without authority and work effectively across global, cross-functional teams
- Executive Presence in working with senior leadership on highly visible initiatives.
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Paid time off
- Flexible work hours
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
digital healthAIsoftware as a medical device (SaMD)data governancealgorithm oversightregulatory complianceprocess designSOP developmentgovernance frameworksimpact assessments
Soft Skills
matrix leadershipinfluence without authoritycollaborationcommunicationexecutive presencerisk managementdecision supportstakeholder engagementcross-functional teamworkcontinuous improvement
Certifications
MDPhDPharmDMBA