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Postdoctoral Research Fellow, Vertex Pharmaceuticals Incorporated, Global Regulatory Affairs

Employer
Northeastern University
Location
Massachusetts, United States
Salary
Salary Not specified
Posted Date
Sep 12, 2022

View more

Position Type
Faculty Positions, Business & Management, Other Business & Management
Employment Level
Post-Doc
Employment Type
Full Time
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Postdoctoral Research Fellow, Vertex Pharmaceuticals Incorporated, Global Regulatory Affairs

About the Opportunity

Job Summary:

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

Global Labeling
  • Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends
  • Lead team in negotiating and maintaining competitive labeling with health authorities globally

Regulatory Strategy
  • 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


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 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 - Vertex).

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 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--Vertex-Pharmaceuticals-Incorporated--Global-Regulatory-Affairs-1_R108846 jeid-81884808ce2cb24193b2ddc785af57d4
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