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Job Description

About the role:

You will be responsible for operational leadership to ensure successful execution of Patient Access programs from planning to close-out. Set-up and manage the operational activities of Patient Access programs

Develop and implement training and communication plans to build awareness, engagement and support for  patient access programs and initiatives across the organization

You will report to the Head of Patient Access, Global Medical

How you will contribute:

• Lead operational activities to set-up and execute expanded access programs in collaboration with the GPA strategy lead.
• Responsible for finalizing program documents , developing the end to end process flow (from triage to drug delivery)
• Responsible for training and communications, program launch, program management and transition and program close-out activities
• Provide expertise and operational guidance related to expanded access programs to cross-functional teams
• Collaborates closely with cross-functional, global and local teams (e.g. Medical affairs, Clinical supplies R&D) to deliver expanded access programs
• Provide operational oversight of budget and drug supply forecasting for Patient Access programs in collaboration with other relevant internal stakeholders (e.g. Finance, Supply Chain).
• ·Responsible for ensuring accurate tracking, reporting, and metrics of Patient access programs (e.g. PSUR, PSMF) in collaboration GPA Systems Lead 
• Manage relationships with key external partners and vendors
• Maintains awareness of worldwide Regulatory guidance support implementation of best practices related to Patient Access across Takeda
• Collaborates closely with other Patient Access teams (e.g. Oncology) and provides operational support for other Patient Access mechanisms and initiatives as needed
• Supports audits and inspections related to Patient Access

Minimum Requirements/Qualifications:

• PhD, PharmD with ~3+years; MS with ~6+ years;  BS with ~8+ years experience or related experience in clinical research or expanded access in the pharmaceutical industry or CRO

Desired:

• Advanced degree in a Health science field preferred (e.g. Nursing, Pharmacy, Public Health).

Previous experience operationalizing expanded access programs preferred

Requires approximately 10% travel, including overnight and international travel to other Takeda sites and meetings with external partners.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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