JOB DETAILS

Job Description PURPOSE OF JOB/POSITION Leading GEM patience access operating model across GEM and local medical and related functional teams.
Driving operation on all regional programs and adhoc cases, interfacing with internal stakeholders in global, regional, and local teams, as well as external vendors, to ensure efficient and compliant provision of access to patients.
Provision of operational oversight of budget and drug supply forecasting for Expanded Access Programs (EAPs) Establishment of central tracking and reporting mechanisms on access mechanisms ACCOUNTABILITIES Patient Access Operations Leading GEM patient access operations, ensuring requests from across GEM are addressed and programs implemented in time, supporting continuous access to treatment for patients in need; Support in implementation of GEM operating model and framework, driving operational effectiveness and efficiencies while ensuring compliance in providing access to patients.
Ensuring smooth transition of Expanded Access vendor managed programs, ad-hoc IPR operations and NPP from Global team to GEM; Cases handling, management and archiving; finalizing program documents, developing the end to end process flow; EAP launch, management, tracking, reporting, transition and program close-out activities.
Program training and communications; Develop product demand plan for EAP, including periodic review and updates to ensure quality and timely delivery of efficient programs Monitor EAPand adhoc cases’ operational performance against established metrics, escalating issues as needed and identifying areas for process improvement.
Problem solve for adhoc issues, ensuring program alignment to stakeholder needs.
Close collaboration with cross-functional, global, regional and local teams to provide expertise, operational guidance and deliver EAP; Provision of operational oversight of budget and drug supply forecasting for EAP in collaboration with other relevant internal stakeholders (e.
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Finance, Supply Chain); Consolidation and establishment of central tracking and reporting mechanisms on existing and new GEM cases.
IPR, IRUP, etc.; Management of relationships with key external partners and vendors; Collaboration with Global Patient Access team and provision of operational support for other Patient Access mechanisms and initiatives as needed.
Provide regular program reports to internal stakeholders, including updates for the relevant cross-functional documents such as PSMF, global trackers, etc FUNCTIONAL KNOWLEDGE Critical functional knowledge Demonstrated understanding of Medical Affairs purpose, patience access and operations.
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 access program operations.
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 CAPABILITIES Critical technical, professional and personal capabilities Bachelor’s in science or related field required Advance degree in science or related field preferred Minimum 5 years of experience in medical affairs, above country level experience is a plus.
Experience in patience access and program management.
Critical leadership capabilities High operational leadersip capabilities in driving complex and time sensitive projects.
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