Patient Access Risk Management Lead, GEM

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

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.g., 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

Worker Type

Worker Sub-Type

Time Type