Northeastern University
Postdoctoral Research Fellow, Vertex-Global Regulatory Affairs | Northeastern Un
Northeastern University, Boston, Massachusetts, us, 02298
Postdoctoral Research Fellow, Vertex—Global Regulatory Affairs
Vertex Pharmaceuticals, Inc., in partnership with Northeastern University, is offering a two‑year Global Regulatory Affairs (GRA) PharmD fellowship based at its corporate headquarters in Boston, Massachusetts.
The fellowship provides specialized training in regulatory strategy and global labeling, with a structured curriculum that includes an elective in a complementary regulatory area (CMC, advertising & promotion, international policy, or strategic operations).
Successful completion of the fellowship prepares the fellow for a career in the pharmaceutical industry.
Responsibilities The PharmD fellow will gain in‑depth training and hands‑on experience in two key GRA domains over an eight‑month period, followed by eight months in a regulatory elective chosen based on the fellow’s interests and departmental needs.
Core Responsibilities Global Labeling
Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends.
Lead the team in negotiating and maintaining competitive labeling with health authorities globally.
Regulatory Strategy
Manage, develop, and implement regulatory strategy to support Vertex products and development programs.
Provide strategic input and tactical support to expedite the development, submission, and regulatory approval of new drug or biologic products.
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.
Application Materials
Curriculum vitae (CV).
Unofficial PharmD transcripts.
Cover letter.
Three formal letters of recommendation (LORs) sent directly to PharmDFellowships@northeastern.edu by November 22, 2024.
Contact 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
Equal Opportunity Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff.
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 to diversity and inclusion, please see the university’s diversity policy page.
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The fellowship provides specialized training in regulatory strategy and global labeling, with a structured curriculum that includes an elective in a complementary regulatory area (CMC, advertising & promotion, international policy, or strategic operations).
Successful completion of the fellowship prepares the fellow for a career in the pharmaceutical industry.
Responsibilities The PharmD fellow will gain in‑depth training and hands‑on experience in two key GRA domains over an eight‑month period, followed by eight months in a regulatory elective chosen based on the fellow’s interests and departmental needs.
Core Responsibilities Global Labeling
Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends.
Lead the team in negotiating and maintaining competitive labeling with health authorities globally.
Regulatory Strategy
Manage, develop, and implement regulatory strategy to support Vertex products and development programs.
Provide strategic input and tactical support to expedite the development, submission, and regulatory approval of new drug or biologic products.
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.
Application Materials
Curriculum vitae (CV).
Unofficial PharmD transcripts.
Cover letter.
Three formal letters of recommendation (LORs) sent directly to PharmDFellowships@northeastern.edu by November 22, 2024.
Contact 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
Equal Opportunity Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff.
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 to diversity and inclusion, please see the university’s diversity policy page.
#J-18808-Ljbffr