Postdoctoral Research Fellow - Pharmacy
- Employer
- Northeastern University
- Location
- Massachusetts, United States
- Salary
- Salary Not specified
- Date posted
- Sep 17, 2020
View more
- Position Type
- Faculty Positions, Professional Fields, Law & Legal Studies
- Employment Level
- Post-Doc
- Employment Type
- Full Time
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Postdoctoral Research Fellow - Pharmacy
About Northeastern:
Founded in 1898, Northeastern is a global research university and a world leader in experiential learning. The same commitment to connecting with the world drives our use-inspired research enterprise. The university offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in nine colleges and schools. Our campuses in Charlotte, N.C., San Francisco, Seattle, and Toronto are regional platforms for undergraduate and graduate learning and collaborative research. Northeastern pursues advanced research in security and materials at the Innovation Campus in Burlington, Massachusetts, and in coastal sustainability at the Marine Science Center in Nahant, Massachusetts.
About the Opportunity:
The Northeastern University Fellowship 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
- Utilize a layered learning model in experiential education by
co-precepting students on pharmacy practice experiences including
Northeastern's unique co-op program
- Create, present, and publish scholarly research through
collaborative industry and university relationships
- Engage with faculty who participate in various
interdisciplinary graduate programs including biotechnology,
nanomedicine, immunology, health informatics, and drug
discovery
- Network with area residents and other Northeastern fellows via
professional development programs, teaching seminars, and
participation on fellowship committees
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.
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. Specific opportunities may vary depending on the interests of the Pharm.D. fellow(s) as well as the needs of the department.
The structured program will provide a cumulative set of skills that will help facilitate a smooth transition to a successful career after the fellowship.
Responsibilities:
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 Vertex and Northeastern. - Strong interest in pursuing a career at Vertex
- 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 in a matrix organization
- Sense of urgency and perseverance to achieve results
- Unquestionable ethics, and professional integrity
Salary Grade:
10
Additional Information:
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 15, 2020:
Applicants should submit the following APPLICATION MATERIALS by the priority deadline of November 15, 2020:
1. Curriculum vitae (CV), uploaded
2. Unofficial PharmD transcripts, uploaded
3. Cover letter, uploaded
Three formal letters of recommendation (LORs) sent directly from the letter writer to PharmDFellowships@northeastern.edu by December 4, 2020. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Vertex, 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.
To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.
To apply, visit https://careers.pageuppeople.com/879/cw/en-us/job/503897
jeid-ef0018874db44748bb809255a24fb307
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