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Details

Posted: 25-Sep-23

Location: Cambridge, Massachusetts

Type: Fellowship

Salary: TBD

Categories:

Pharmacy

Job Setting:

Other

Pharmaceutical Science/Industry

Specialty Practice Areas:

Research

Salary Details:

The fellow will receive a competitive stipend and benefits package, including comprehensive health and dental insurance. Attendance at one or more professional meetings, conferences or workshops will be sponsored by the fellowship

Required Education:

PharmD

Global Regulatory Labeling Strategy Overview 

At Takeda, the Global Regulatory Labeling Strategy fellowship program will provide an opportunity to provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory requirements. Serve as the regulatory expert for labeling on the Global Regulatory Affairs (GRA) Sub-team to ensure that regulatory labeling requirements are met for assigned products. The fellow will contribute to development and life-cycle management of product labels, through this will acquire a better understanding of the end-to-end labeling process as well as the overall drug development process. 

Global Regulatory Affairs Labeling Strategy at Takeda

•    Drive development and delivery of essential, innovative, industry-leading product labeling to patients and health care professionals
•    Utilize the first-hand working knowledge of the regulatory requirements for creating and maintaining scientifically driven product labeling in collaboration with cross-functional teams
•    Strategically guide product labeling across entire product lifecycle
•    Lead and Support development and maintenance of Company Core Data Sheet (CCDS) to ensure a consistent and accurate company position on the safety and efficacy of our products in partnership with cross-functional teams
•    Collaborate with cross-functional teams to provide strategic labeling expertise for label development and to enhance opportunity
•    Ensure robust processes for global implementation of labeling content (new data, safety information etc.) for appropriate use in patients globally

The fellow will be selected on a nationally competitive basis. 
To be eligible, candidates must be graduates of an Accreditation Council for Pharmacy Education (ACPE) accredited Doctor of Pharmacy Program before the fellowship begins in July. Participation in the American Society of Health-Systems Pharmacist (ASHP) Midyear Clinical Meeting Personnel Placement Services (PPS) is strongly encouraged, but not required. The candidate must be eligible to work in the United States, as Purdue and Takeda will not provide sponsorship to foreign students.

•    Curriculum Vitae
•    Letter of Intent
•    Official College of Pharmacy Transcript
•     Three letters of Recommendation

Email: GRALabelingfellowship@takeda.com

About Purdue University / Takeda

Please see website for further information.

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