Northeastern University’s Pharmaceutical Industry Fellowship Program is a two-year fellowship designed to advance the education and training of Pharm.D. or Ph.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, Takeda Pharmaceuticals is offering a two-year Global Regulatory Affairs PharmD fellowship based in Cambridge, MA.
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 Takeda Pharmaceutical Company:
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
Plasma-derived therapies are critical, life-saving medicines that thousands of people with rare and complex diseases rely on every day around the world. The Plasma Derived Therapies Business Unit within Takeda focuses on reimagining plasma and going beyond incremental improvements to find a wide range of innovative and sustainable solutions to better serve patients. Our expertise, capabilities, and scale uniquely position us to transform plasma across our entire end-to-end operations and make a positive impact on people’s lives.
The Global Regulatory Affairs two-year fellowship is designed to provide post-doctoral graduates with an in-depth understanding of regulatory affairs and the drug development process through rotations within global regulatory strategy, labeling, and Chemistry, Manufacturing, and Control functions.
In each rotation, fellows will receive mentorship, guidance, and have opportunity to work with staff across various geographies and learn to navigate the complex dynamics and team environment at a truly global pharmaceutical company.
Develop regulatory strategy by using and interpreting regulations and guidelines
Provide support to the life-cycle management activities pre- and post-approval for plasma-derived therapies, and gain an understanding of the principles of agency review processes
Gain an understanding of early and late phase clinical development and gain expertise in the requirements of regulatory submissions to global health authorities
Understand the various facets of global regulatory affairs, including labeling, regulatory intelligence and strategy, and chemistry manufacturing and controls (CMC)
Participate in departmental initiatives for process improvements
Strategically guide product labeling across entire product lifecycle
The fellows will primarily work at Takeda’s office in Cambridge, Massachusetts. Northeastern University responsibilities will be carried out on the Northeastern Boston campus.
Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts OR Doctor of Philosophy degree in a biological or physical science.
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.
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 1st , 2023:
Curriculum vitae (CV), uploaded
Unofficial PharmD or PhD transcripts, uploaded
Cover letter, uploaded
Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by November 29th, 2021. 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
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.