Vertex Pharmaceuticals-Global Regulatory Affairs Postdoctoral Research Fellow

Northeastern University•Boston, MA

About The Position

About the Opportunity About the Opportunity Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. A key element of the program’s success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities. In partnership with Northeastern University, Vertex Pharmaceuticals Incorporated (Vertex) is offering a two-year Global Regulatory Affairs (GRA) fellowship, based in Boston, MA. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous, nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 15 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 LinkedIn, Facebook, Instagram, YouTube and X.

Requirements

Doctor of Pharmacy degree from an ACPE-accredited institution
Eligible for pharmacist licensure in the State of Massachusetts
Excellent oral and written communication skills
Strong time management and leadership abilities
Ability to work independently and take initiative on a variety of projects at both the industry site and Northeastern

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