Postdoctoral Research Fellow, Vertex Pharmaceuticals Incorporated, Global Regulatory Affairs
Location: BOSTON, Massachusetts
Required Education: PharmD
Internal Number: R108846
The Northeastern University Pharmaceutical Industry Fellowship program will not accept PPS candidate interview requests.
Candidates will need to apply in advance through the Northeastern University career portal.
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Position: Northeastern University Postdoctoral Research Fellow, Vertex Pharmaceuticals Incorporated, Global Regulatory Affairs
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
Vertex Pharmaceuticals Incorporated
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. In addition to clinical development programs in the respiratory, nephrology, pain, and cell and gene therapy disease space, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other rare diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 4,300 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. At Vertex, we have some of the industry's best and brightest people helping us achieve our mission of discovering transformative medicines to help people with serious diseases. We depend on a talented global workforce to lead the charge as we work toward developing tomorrow's breakthrough medicines. The broad background possessed by a Pharm.D. graduate is highly valued in the Biopharmaceutical Industry, and certainly here at Vertex.
Global Regulatory Affairs
Vertex is offering a 2-year PharmD Fellowship in Global Regulatory Affairs (GRA) at the corporate headquarters in Boston, Massachusetts. The PharmD fellow(s) will have an
opportunity to gain specialized and in-depth training in two distinct areas of GRA, Regulatory Strategy and Global Labeling for a period of 8 months. The remaining 8 months of the program will be spent in a regulatory elective. Specific opportunities may vary depending on the interests of the PharmD fellow(s) as well as the needs of the department. Overall, the structured program will provide a cumulative set of skills that will help facilitate a smooth transition to a successful career after the fellowship.
Responsibilities - Core Responsibilities
Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends
Lead team in negotiating and maintaining competitive labeling with health authorities globally
Manage, develop, and implement regulatory strategy in support of 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
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 Vertex and Northeastern.
Strong interest in pursuing a career at Vertex
Strong verbal, written communication, interpersonal, listening, and organizational skills
Ability to work in a diverse environment
Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
Sense of urgency and perseverance to achieve results
Unquestionable ethics, and professional integrity
Additional Information: Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31st, 2022:
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 28th, 2022. 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
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.
The NORTHEASTERN FELLOWSHIP PROGRAM provides fellows with dynamic biopharmaceutical industry experiences with the benefits of an academic environment. Over two-years, fellows work at one of the partner companies located in the greater Boston and Cambridge, MA areas and at Northeastern University’s School of Pharmacy.
LEARN MORE at NUfellowship.com.