About Northeastern: Founded in 1898, Northeastern is a global research university and the recognized leader in experience-driven lifelong learning. Our world-renowned experiential approach empowers our students, faculty, alumni, and partners to create impact far beyond the confines of discipline, degree, and campus.
Our locationsin Boston; Charlotte, North Carolina; London; Portland, Maine; San Francisco; Seattle; Silicon Valley; Toronto; Vancouver; and the Massachusetts communities of Burlington and Nahantare nodes in our growing global university system. Through this network, we expand opportunities for flexible, student-centered learning and collaborative, solutions-focused research.
Northeastern's comprehensive array of undergraduate and graduate programs in a variety of on-campus and online formatslead to degrees through the doctorate in nine colleges and schools. Among these, we offer more than 195 multi-discipline majors and degrees designed to prepare students for purposeful lives and careers.
About the Opportunity:
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 cystic fibrosis (CF), 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 2,500 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.
Responsibilities: Vertex is offering a two-year Biopharmaceutical Industry Fellowship in Global Regulatory Affairs at the corporate headquarters in Boston MA. The Pharm.D. fellow(s) will have an opportunity to gain specialized and in-depth training in three-distinct areas of Global Regulatory Affairs including Regulatory Strategy; Global Labeling; and Advertising and Promotion for a period of six-months. The remaining six-months of the program will be spent in the area of global regulatory affairs where the Pharm.D. fellow(s) can envision beginning their career journey.
The structured program will provide a cumulative set of skills that will help facilitate a smooth transition to a successful career after the fellowship.
North America Regulatory Strategy Primary Objectives Manages, develops, and implements regulatory strategy in support of Vertex products and development programs
Support the planning, preparation and execution of high-quality regulatory submissions (e.g. IND/IND amendment, NDA/sNDA, DSUR, PSUR, CTA, and NDS/sNDS, etc.)
Ensure compliance of regulatory strategies and submissions with current regulations and guidance including title 21 CFR, FDA and ICH guidelines
Work in cross-functional team including clinical, statistics, medical affairs, commercial, and nonclinical groups to help operationalize regulatory strategy
Serves as regulatory contact for Regulatory Health Authorities
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), Structured Product Labeling (SPL), or Instructions for Use (IFUs).
Support development of regulatory labeling strategy and lead team in negotiating and maintaining competitive labeling with Health Authorities globally
Author and maintain core labeling documents including the Target Labeling Profile (TLP)
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 Conduct 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 recommends revisions/actions that balance risks and opportunities.
Manage the review and approval of promotional and non-promotional materials in a cross-functional team that includes commercial, medical affairs, and legal
Responsible for timely and accurate review of all materials for submission to FDA, including Form FDA 2253
Serve as member of the promotional review committee to ensure regulatory compliance for all communications
Liaison with OPDP regarding advertising and promotion for assigned products
Qualifications: Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.
Preferred Qualifications: 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.
Salary Grade: 10
Additional Information: Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 1st , 2021:
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, 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
360 Huntington Ave, 140TF R218
Boston, MA 02115
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.
Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in worldwide experiential learning, urban engagement, and interdisciplinary research that meets global and societal needs. Our broad mix of experience-based education programs?our signature cooperative education program, as well as student research, service learning, and global learning?build the connections that enable students to transform their lives. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools.