Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Postdoctoral Research Fellow
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
Ipsen Biopharmaceuticals Ipsen Biopharmaceuticals, Inc. is launching a 2-year post-PharmD fellowship in U.S. Medical Affairs and Regulatory Affairs in collaboration with Northeastern University, School of Pharmacy.
Ipsen is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. Our presence in North America dates back to 1976, and now includes Ipsen's third global hub right in the heart of the leading global biotech ecosystem in Cambridge, Mass., where a fully integrated biopharmaceutical team across External Innovation and Partnering, R&D, Manufacturing and Commercial operations collaborates. With Ipsen's expansion of its footprint in Cambridge, and new North America headquarters in Kendall Square, the group is building a sustainable innovation engine within the biotech community.
This two-year Fellowship Program in collaboration with Northeastern University and Ipsen is designed to provide Doctor of Pharmacy graduates an opportunity to gain in-depth experience in the biopharmaceutical industry within Ipsen's Medical and Regulatory Affairs. At Ipsen, we have a clear mission: to improve patients' lives. We are a dynamic and growing global biopharmaceutical leader focused on innovation and specialty care, with a focus on 3 core areas: oncology, neuroscience, and rare diseases.
Areas of Focus for the PharmD Fellowship Program include: U.S. Medical Affairs rotation may include (choice of 2 areas*): Medical Information, Medical Strategy, Thought Leader Engagement, Scientific Communications and Publications, Health Economics and Outcomes Research, Medical Affairs Training
Regulatory Affairs rotation will include: US Commercial Regulatory Affairs, Global Regulatory Labeling
*Other cross-functional experiences as discussed per candidate aspirations
The program consists of a 1-year rotation through the Medical Affairs team and 1- year rotation through the Regulatory Affairs team. The PharmD Fellow also participates in the Northeastern University seminars/events/teaching opportunities. The fellow will work virtually and/or on-site at Ipsen in Cambridge, MA, and virtually and/or on-site at Northeastern University.
About the role:
Understand various roles, processes and industry standards involved in the US Medical Affairs, US Commercial Regulatory and Global Regulatory Labeling areas at Ipsen Biopharmaceuticals, Inc.
Assist in the creation of medical information response documents
Be an active contributor to the team to develop/launch medical strategies within the Medical Affairs Teams
Contribute to the review of promotional and medical materials
Work closely with Medical Affairs team to develop training and scientific education for internal and external stakeholders
Collaborate with cross-functional teams (regulatory, marketing, sales, legal, clinical development) to provide and communicate the most up to date scientific information as a subject matter expert
Learn how to develop strategic scientific communication plans in a cross-functional manner
Partner with Medical Directors /Health Economics Directors to develop scientific materials that align with the scientific communication materials that align with the scientific communication plan (e.g. manuscripts, abstracts, posters, slide decks).
Learn the basic tenants of US promotional labeling regulations and apply to the regulatory review of marketing materials
Support continuous improvement of US promotional review process through evaluation and revising Work Instruction and Standard Operating Procedure documents
Interpret and summarize for US affiliate colleagues new FDA Guidance Documents identifying impact to the company
Liaise with commercial stakeholders and compliance functional partners to help identify areas of vulnerability and offer mitigation strategies
Conduct competitor regulatory intelligence analysis, liaise with functional partners and present opportunities for objection handling, competitor complaint and/or revising promotional claims
Evaluate and revise promotional regulatory internal training documents
Work cross functionally to establish and maintain core company data sheet for IPSEN products
Manage required labelling updates, proofreading, and version control
Manage quality control over core company data sheet labelling process
Maintain tools that support coordination with other functions (e.g., Product distribution lists)
Communicate and disseminate newly approved core company data sheet to internal stakeholders
Maintain and catalogue all labelling materials in accordance with company policies, procedures, and technologies.
Gain experience and skills to be a successful member of a Medical or Regulatory Affairs department in the biotech industry. Ipsen Contact Email: PharmDFellowship.USA@ipsen.com
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 15, 2020:
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 - IPSEN, 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.