Postdoctoral Research Fellow - Global Regulatory Affairs
About Northeastern: Founded in 1898, Northeastern is a global research university and a world leader in experiential learning. The same commitment to connecting with the world drives our use-inspired research enterprise. The university offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools. Our campuses in Charlotte, N.C., San Francisco, Seattle, and Toronto are regional platforms for undergraduate and graduate learning and collaborative research. Northeastern pursues advanced research in security and materials at the Innovation Campus in Burlington, Massachusetts, and in coastal sustainability at the Marine Science Center in Nahant, Massachusetts.
About the Opportunity: The Northeastern University Fellowship Program provides a dynamic academic environment offering fellows the opportunity for a wide breadth of experiences:
Develop teaching skills through participation in our Teaching and Learning Seminar series
Facilitate small and large group didactic education in partnership with a faculty mentor
Utilize a layered learning model in experiential education by co-precepting students on pharmacy practice experiences including Northeastern's unique co-op program
Create, present, and publish scholarly research through collaborative industry and university relationships
Engage with faculty who participate in various interdisciplinary graduate programs including biotechnology, nanomedicine, immunology, health informatics, and drug discovery
Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees
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 cancer immunotherapy, we combine our leading expertise in protein kinases with a uniquely targeted, scalable approach to empower the rapid design and development of transformational medicines.
Global Regulatory Affairs: 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 IND and NDA submissions to FDA, and life cycle management of Blueprint Medicines' pre- and post-approval programs. In addition, the fellow will collaborate on a daily basis 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 FDA 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< Qualifications: Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.
Preferred Qualifications: 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.
Salary Grade: 10
Additional Information: Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 15, 2020:
Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by December 4, 2020. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - GSK, Deciphera).
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
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.
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.