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Job Description

About the role:

You will lead compliance activities including process development, audits and inspections for Patient Access. Responsible for strategic planning, implementation and management of continuous improvements, training and best practices to ensure regulatory compliance and consistency for Takeda Patient Access programs. Responsible for providing day-to-day compliance and process oversight of Patient access programs and initiatives.

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

How you will contribute:

• Lead the development, update, maintenance, and implementation procedural documents, processes and templates managed by Patient Access

• Develop, coordinate, and oversee training for Patient Access processes and procedures

• Drive process enhancement and continuous improvement initiatives in Patient Access

• Lead regulatory inspections and audit support for Patient Access, including managing pre-inspection/audit document requests, ensuring accurate timely delivery of document

• Contribute to the development of robust responses and CAPAs to inspection/audit findings for Patient Access. Coordinate and support the tracking of corrective actions for inspection/audit findings related to patient access, ensuring timelines are met

• Lead the planning and execution of global tracking and maintenance of Patient Access programs, and ensure entry and accuracy

• Responsible for the development of the Patient Access monthly report and communication with stakeholders regarding monthly update of Patient access information

• Responsible for updating and maintaining the Patient access Regulatory Strategy Database and country-specific educational materials

• Maintains awareness of worldwide Regulatory guidance and support the implementation of best practices related to Patient Access across Takeda

• Responsible for the review and update of Patient Access information in the Pharmacovigilance System Master File (PSMF), ensuring completeness and accuracy

• Collaborates closely with cross-functional, global and local teams to ensure compliance and consistency in the execution of Patient Access programs across Takeda

• Responsible for monitoring and maintenance of the Global Patient Access mailbox and maintaining SharePoint sites

Minimum Requirements/Qualifications:

• PhD, PharmD with 8+years; MS with 12+ years; BS with 14+ years experience or related experience in clinical research or expanded access in the pharmaceutical industry or CRO

• Previous experience with leading compliance and process improvement initiatives.

Desired:

• Advanced degree in a Health science field

• Previous experience working in expanded access

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.

#LI-Hybrid

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - MA - Cambridge - Kendall Square - 500

U.S. Base Salary Range:

$149,100.00 - $234,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Cambridge - Kendall Square - 500

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time