PATIENT ACCESS RISK MANAGEMENT LEAD, GEM

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Job Description PURPOSE OF JOB/POSITION Lead as point of excellence on patience access matters in Growth & Emerging Markets (GEM) medical teams to ensure expanded access to treatments for patients in need with sustainability.
Drive patience access strategic planning, framework development and implementation of patient access and risk management models, including non-trial pre-approval access programs Drive systematic risk management in medical affairs by close business partnering to ensure risk preparation, monitoring and mitigation.
ACCOUNTABILITIES Patient Access & Risk Management Drive strategic planning and devleop operating model with guidance for all GEM patience access programs and mechanisms (eg.
IPR, NPP, IRUP, etc).
Develop and implement capability building both internally and externally to address patient access barriers and establish Takeda as a leader in global healthcare.
Oversee compliance with the functioning of expanded access programmes and any access mechanisms in Takeda.
Partner with stakeholders and teams to ensure successful implementation and execution of GEM patient access operation model.
Conduct regular monitoring of expanded access programmes and develop guidelines for continuous improvement.
Verify that all documents required for the operation of access mechanisms are completed in a timely and proper manner, including managing the delegation of signatures for the involved personnel.
Lead and develop training and communication plans to build awareness and understanding of patient access programs and initiatives to key stakeholders within the region.
Communicate and train teams on patient access principles and policies within and across the organization to support a patient centric culture.
Partner with stakeholders such as AtM, global HEPA, legal, Pharmacovigilance and others to ensure GEM patience access operations alignment with other function’s responsible mechanisms (eg.
Compassionte use, etc).
Perform periodic review and revision on GEM patience access operating model and strategic planning to align with organizational aspirations on providing access to treatments.
Ensure compliance monitoring of corrective actions to improve processes and operations in the different programme.
Conduct GAP assessments of the procedures and processes involved in the management of the different access mechanisms.
Update and/or Update or establish guidelines and procedures for the operation of expanded access programs, access mechanisms, and their appropriate transitions.
Guidance the transition of access mechanisms as needed (e.
., from NPP to IPR, IPR to PAP, or vice versa).
Develop holistic regional risk management plans in partnership with global and cross-functional stakeholders for patient access.
Recording, follow-up, and monitoring of identified risks, along with the implementation of mitigation measures.
FUNCTIONAL KNOWLEDGE Critical functional knowledge Demonstrated understanding of Medical Affairs purpose, patient access and risk management Demonstrated understanding business context and regulatory and legal environments related to patient access and risks.
Deep understanding of access to treatments, expanded and/or early access mechanisms and related policies, as well as risk management.
Understanding of global regulations related to expanded access Project management experience related to expanded access, including Ability to build consensus across multiple functional stakeholders Vendor management/oversight and experience working with supply chain Budget management and drug supply forecasting Strong skills and knowledge in GCP, quality and/or clinical development.
CAPABILITIES Critical technical, professional and personal capabilities Bachelor’s in science or related field required Advance degree in science or related field preferred Minimum 8 years of experience in medical affairs, above country level experience is a plus.
Experience in patient access, risk management and/or medical governance.
Critical leadership capabilities High strategic enterprise thinking capabilities, holistic view on patient access and risk management for the organization.
Ability to manage global and complex situations and quickly adapt to changing dynamics.
Ability to influence others in matrix setting to achieve alignment and consensus Ability to work in a cross-functional, cross-cultural, and competitive business setting Demonstrating excellent listening and decision-making skills Excellent written and oral communications, and presentation skills Self-driven and clear track record of results delivery Proven skills as an effective team player who can engender credibility and confidence within and outside the company Locations Singapore, Singapore Worker Type Employee Worker Sub-Type Regular Time Type Full time