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, Eidos Therapeutics, Inc. a BridgeBio Company is offering a two-yearRegulatory Affairs PharmD fellowship based in San Francisco, California.
About Eidos Therapeutics, Inc. a BridgeBio Company
Eidos Therapeutics, Inc. a BridgeBio Company is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, acoramidis (AG10), is an orally-administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases?and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.?
Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.
The program consists of a 2-year assignment within the Regulatory Affairs team and may be eligible for rotation within another function, eg. Clinical Development, Clinical Operations, and Medical Affairs. The PharmD Fellow will remote and work on-site and at Eidos Therapeutics, Inc. a BridgeBio Company in San Francisco, CA.
Regulatory Strategy Primary Objectives
Manage, develop, and implement regulatory strategy in support of Eidos development programs
Support the planning, preparation and execution of high-quality regulatory submissions (e.g. CTA/IND and amendments, annual reports, initial license applications (NDA/MAA, etc.) and supplements/variations)
Develop and maintain knowledge of ICH, GCP, GMP, and other relevant global guidelines to ensure compliance of regulatory strategies and submissions
Work in cross-functional teams including clinical, statistics, medical affairs, commercial, and nonclinical groups to help operationalize regulatory strategy
Support regulatory interactions with regulatory bodies including preparation of meeting requests and briefing documents
Global Labeling Primary Objectives
Gain in-depth knowledge of labeling regulations regarding Company Core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), and Structured Product Labeling (SPL)
Support development of regulatory labeling strategy and the negotiation and maintenance of competitive labeling with global Health Authorities
Maintain core labeling documents
Provide strategic guidance on labeling regulations, competitor labeling, and labeling trends and work with cross-functional team to ensure that the regulatory labeling strategy is aligned with the global regulatory strategy
Assist in preparation of responses to labeling-related queries from Health Authorities
Advertising and Promotions Primary Objectives
Support regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, health authority regulations, ICH guidelines, PhRMA guidelines, company policies and established precedents and recommend revisions/actions that achieve fair balance.
Support the review and approval of promotional and non-promotional materials in a cross-functional promotional review committee that includes commercial, medical affairs, and legal
Coordinate timely and accurate review of materials for submission to FDA
Support regulatory reviewer for the promotional review committee to ensure regulatory compliance for all communications
Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts and/or California.
Excellent oral and written communication, time management, and leadership skills, ability to work independently and take initiative on a variety of projects at Eidos and Northeastern.
Strong interest in pursuing a career at Eidos and BridgeBio
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
Sense of urgency and perseverance to achieve results
Unquestionable ethics, and professional integrity
Applicants must upload application materials to the Northeastern University Workday Career Portal (this position will become available for candidates to apply in November; however, you may request an interview beforehand:
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 byDecember 1st, 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:
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.