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Postdoctoral Research Fellow, Blueprint--Regulatory Affairs
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Position Number: 5638614
Location: Boston, MA
Position Type: Medicine - Pharmacology

Postdoctoral Research Fellow, Blueprint--Regulatory Affairs

About the Opportunity

About the Opportunity:

Northeastern University's Pharmaceutical Industry Fellowship Program is a two-year fellowship designed to advance the education and training of Pharm.D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas. The program is a collaboration between Northeastern University and biopharmaceutical industry partners.

In partnership with Northeastern University, Blueprint Medicines is offering a two-year Regulatory Affairs PharmD fellowship based in Cambridge, MA.

About Blueprint Medicines:

Blueprint Medicines will offer three 2-year Fellowship Programs in collaboration with Northeastern University designed to offer Doctor of Pharmacy graduates an in-depth experience in a biopharmaceutical industry setting. Blueprint Medicines is a global precision therapy company striving to improve human health. With a focus on genomically defined cancers, rare diseases, and immunology, we combine our leading expertise in protein kinases with a uniquely targeted, scalable approach to empower the rapid design and development of transformational medicines.

Responsibilities:

The Regulatory Affairs Fellowship at Blueprint Medicines offers a great opportunity to complement one's PharmD training with hands-on regulatory experience within a rapidly growing biotechnology company. The fellow will work with Blueprint Medicines' clinical development teams and engage in projects on initiating/supporting global clinical trials, preparing investigational and approval application submissions to global health authorities like FDA, and life cycle management of Blueprint Medicines' pre- and post-approval programs. In addition, the fellow will collaborate with professionals across the organization including Commercial, Clinical Development, Manufacturing, Medical Affairs, and Preclinical Development. Given the breadth of product portfolio of Blueprint Medicines, this fellowship is a unique opportunity for exposure to a broad set of regulatory experiences in a short period of time.

Key workstreams may include:

Manage the development and execution of regulatory submissions for assigned projects.

Contribute to the development of regulatory strategy for life cycle management of Blueprint Medicines clinical programs

Summarize key insights from global drug approvals, applying lessons to Blueprint Medicines clinical programs.

Collaboration with internal and external partners across drug development and commercialization continuum Develop and deliver presentations as needed to the regulatory team and other internal groups.

Contribute to activities in support of high-quality regulatory documentation.

Qualifications:

Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.

Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at the industry site and Northeastern.

Additional Information:

Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31, 2024

Curriculum vitae (CV), uploaded

Unofficial PharmD transcripts, uploaded

Cover letter, uploaded

Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 22nd, 2024. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Alnylam, GSK).

Address cover letter and three LORs to:

J. Andrew Orr-Skirvin, PharmD, BCOP

Clinical Professor, School of Pharmacy

Chair, Department of Pharmacy & Health System Sciences

Director of Pharmaceutical Industry Fellowship Program

360 Huntington Ave, 140TF R218

Boston, MA 02115

Position Type

Research

Additional Information

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.

Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.

Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.

All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.

To apply, visit https://northeastern.wd1.myworkdayjobs.com/en-US/careers/job/Boston-MA-Main-Campus/Postdoctoral-Research-Fellow--Blueprint--Regulatory-Affairs_R127482