Director, PV Risk Management - Takeda

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Job Description

Takeda Development Center Americas, Inc. is seeking a Director, PV Risk Management in Cambridge, MA with the following requirements: Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, Public Health, or life sciences or related field or foreign academic equivalent plus 8 years related experience. Prior experience must include: Strategize, author, and review Global and European Risk Management Plans (RMP) Core-RMP, EU-RMP other RMP including those for first or supplementary marketing authorizations applications (NDA submissions); Advise product team on the maintenance and implementation of REMS program for assigned product and support FDA response requests; Support health authority inspections and audits (on behalf of the company) for assigned products including supporting FDA Inspections and MHRA (The Medicines and Healthcare products Regulatory Agency) inspections; Engage in cross-functional strategic discussions for management of activities including planning, authoring and review of periodic aggregate reports like Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER/PAER) in compliance with global regulations. Up to 5% travel required. Up to 100% remote work allowed from anywhere in the US. Apply on-line at www.takedajobs.com and search for Req #R0118571

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Director, PV Risk Management

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Director, PV Risk Management with the following duties: Provide global strategic leadership and expertise in risk management across therapeutic areas; advise teams on the strategy, authorship, and maintenance various risk management materials for regulatory submissions for first or supplementary Marketing Authorization Application (MMA) and New Drug Application (NDA) submissions; advise on the strategy, preparation and authoring of risk management plans (RMPs) for company products; lead the planning and development of additional risk minimization measure and tools; ensure regional standard practices for risk management are consistent with global risk management policies; collaborate with global and local colleagues to ensure compliance with local and global regulations to receive drug approvals or renewals; collaborate with cross-functional stakeholders and third-party vendors to deliver risk management materials such as RMPs, aRMMs, REMS and tracking regulatory commitments. Up to 5% travel required. Up to 100% remote work allowed from anywhere in the US.

REQUIREMENTS: Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, Public Health, or life sciences or related field or foreign academic equivalent plus 8 years related experience. Prior experience must include: Strategize, author, and review Global and European Risk Management Plans (RMP) Core-RMP, EU-RMP other RMP including those for first or supplementary marketing authorizations applications (NDA submissions); Advise product team on the maintenance and implementation of REMS program for assigned product and support FDA response requests; Support health authority inspections and audits (on behalf of the company) for assigned products including supporting FDA Inspections and MHRA (The Medicines and Healthcare products Regulatory Agency) inspections; Engage in cross-functional strategic discussions for management of activities including planning, authoring and review of periodic aggregate reports like Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER/PAER) in compliance with global regulations. Up to 5% travel required. Up to 100% remote work allowed from anywhere in the US.

Full time. $195,200 - $283,200 per year. Competitive compensation and benefits.

Qualified applicants can apply at Takeda careers page at: https://www.takedajobs.com. Please reference job #R0118571. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

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:

U.S. Base Salary Range:

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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-termincentives. 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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time