Register for the 2023 Personnel Placement Service (PPS) to request an interview.

Details

Posted: 10-Oct-23

Location: BOSTON, Massachusetts

Type: Fellowship

Categories:

Pharmacy

Required Education:

PharmD

Additional Information:

Employer will assist with relocation costs.

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.

Our 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
• Create, present, and publish scholarly research through collaborative industry and university relationships
• Engage with faculty who participate in various interdisciplinary
• Network with area residents and other Northeastern fellows via professional development programs, teaching seminars, and participation on fellowship committees

In partnership with Northeastern University, Vertex Pharmaceuticals Incorporated (Vertex) is offering a two-year Global Regulatory Affairs (GRA) PharmD fellowship based at the corporate headquarters in Boston, Massachusetts.

We are not accepting PPS interview requests. Applicants must apply through our career portal to be considered for this position. Apply today using the link at the end of this posting!

About Vertex:

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust clinical pipeline of investigational small molecule, mRNA, cell and genetic therapies (including gene editing) in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes and alpha-1 antitrypsin deficiency.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Responsibilities:

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. Regulatory elective opportunities are offered in areas including CMC, CoRA, International, Policy, and Strategic Operations. 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. 

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 31, 2023

• 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 29th , 2023. 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

Apply Today!

About Northeastern University

Northeastern University Pharmaceutical Industry Fellowships Program offers a variety of two-year post-PharmD research fellowships. We aim to provide fellows with a dynamic environment to develop industry and academic skills to be leaders in their fields. With the rich biopharmaceutical landscape of Greater Boston as a backdrop, our programs offer the fellow an opportunity to work with innovative industry partners in a variety of specialty areas while partnering with Northeastern University faculty in the areas of research, scholarship, and teaching.

Connections working at Northeastern University