Postdoctoral Research Fellow

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:
Ipsen Biopharmaceuticals, Inc. is launching a 2-year post-PharmD fellowship in U.S. Medical Affairs and Commercial Regulatory 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.

Responsibilities:

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 1^st , 2021:

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 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.

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/507721





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