Patient Services Governance Lead
PharmaPharmacovigilanceRegulatory AffairsQuality Assuranceheormedicalpharmacovigilanceemacroinform
Job description
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role The Patient Services Governance Lead provides enterprise-level governance leadership for Patient Services and related patient support activities across the patient journey. The role focuses on PSPs and other structured services that support diagnostic testing, access and reimbursement, treatment start and administration, home care or treatment logistics, adherence, monitoring, and ongoing disease or wellbeing support. It may also provide governance input for patient education and awareness activities where these require dedicated Patient Services review. Operating within the Medical Governance Office, this role establishes and maintains clear standards, decision criteria, review pathways, documentation expectations, and oversight requirements for these activities. The role helps teams determine the appropriate governance approach for PSPs, diagnostic services, and other patient-facing support, ensuring that the right Medical, Ethics & Compliance, Pharmacovigilance, Quality, Regulatory, Privacy, Legal, Digital/DD&T, Access, Procurement, and Vendor Management reviews are built into the process where relevant. The role balances compliance rigor with practical execution, enabling responsible innovation through simple tools, templates, clear accountabilities, and consistent ways of working across markets. Working closely with Strategic Portfolio Division (SPD), Marketing and Commercial Excellence (MCE), and local market organizations, the role helps translate enterprise governance standards into compliant local execution aligned to patient journey needs, healthcare-system realities, and country-specific regulatory requirements. It does not own Patient Services strategy, asset-level launch planning, or local program delivery; instead, it provides the governance standards, risk-management framework, and advisory support needed for compliant, scalable, and patient-centric execution globally The role also serves as a key Medical Governance Office partner to Digital/DD&T and Patient Solutions stakeholders, ensuring that digital patient services, technology-enabled patient support programs, patient-facing platforms, and emerging AI-enabled solutions are governed through appropriate risk-based oversight, data governance, privacy, security, quality, and compliance frameworks. This includes helping define governance standards for increasingly integrated digital and non-digital patient support ecosystems. Recent governance discussions have emphasized the need to synchronize digital and non-digital patient service governance and clarify ownership across overlapping governance domains. How you will contribute Establish, maintain, and evolve enterprise governance standards for Patient Services to ensure consistent quality, transparency, accountability, appropriate oversight, and compliance across markets. Define practical decision criteria and review tools that help teams determine whether an activity should follow PSP governance, diagnostic service governance, or another appropriate patient support governance pathway. Partner with SPD, MCE, LOC Patient Services leaders, and country organizations to establish governance frameworks that enable compliant local implementation of patient support solutions while maintaining alignment with enterprise standards, local patient journey requirements, evolving regulations, and global risk-management expectations. Define lifecycle governance expectations for Patient Services and PSPs, from concept/intake through review, approval, implementation readiness, monitoring, change management, and close-out or retirement, ensuring clear documentation and accountability at each stage. Translate governance expectations into usable operating materials, including intake questions, checklists, templates, documentation requirements, SOP/standard inputs, training materials, and knowledge-management resources. Enable consistent governance review by coordinating required functional input from Medical, Ethics & Compliance, Pharmacovigilance, Quality, Regulatory, Privacy, Legal, Digital/DD&T, Access, Procurement, Vendor Management, and local Medical teams where relevant, ensuring governance decisions appropriately reflect both enterprise risk considerations and local execution realities. Assess new, changing, or scaled Patient Services and related patient support activities to determine the appropriate governance pathway, required functional review, documentation expectations, and oversight needs. Maintain visibility of emerging patient support models across markets, identifying trends, common risks, and opportunities for harmonization, simplification, and scalable governance approaches that balance global consistency with necessary local flexibility. Define enterprise expectations for third-party governance in Patient Services and PSPs, including role clarity, qualification expectations, training, documentation, oversight, issue escalation, and performance visibility, while local or program owners remain accountable for vendor execution and day-to-day management. Provide governance advisory support for new, changing, or scaled patient support models, including launch-related PSPs, diagnostic services, access support, treatment-start services, and home care or monitoring models, while not owning asset strategy, launch execution, or local implementation. Build and maintain governance visibility for Patient Services and related patient solutions through inventories, repositories, documentation standards, review status tracking, issue visibility, follow-up actions, and leadership-ready summaries. Support audit readiness, governance reviews, risk assessments, gap analyses, remediation planning, issue escalation, and CAPA-related activities for Patient Services / PSP governance, in collaboration with the broader Medical Governance Office and relevant enterprise functions. Define and continuously evolve governance standards for digital patient services, including patient portals, digital adherence programs, remote monitoring solutions, patient applications, AI-enabled support capabilities, and other technology-enabled patient engagement models, ensuring responsible innovation while protecting patient safety, privacy, trust, and regulatory compliance. Bring responsible innovation by introducing reusable tools, digital intake and workflow solutions, governance automation, dashboards, analytics, AI-enabled oversight capabilities, and continuous-improvement practices that improve transparency, efficiency, risk visibility, and governance effectiveness without adding unnecessary bureaucracy. Represent the Medical Governance Office in relevant PSP, diagnostic services, patient support, vendor, data/digital, and cross-functional governance discussions, ensuring enterprise governance expectations are clearly understood and practically embedded. Capture and share learnings, best practices, and common market needs to strengthen the enterprise governance foundation.
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