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Director, PV Risk Management

Employer
Takeda
Location
Boston, Massachusetts
Start date
Jun 16, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

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’sPrivacy Noticeand 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

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.

Full time. $196,000 - $283,200 per year.

Apply on-line at https://jobs.takeda.com and search for Req #R0123103.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com.

Stock Symbol: TAK

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
US

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