About the Opportunity

About the Opportunity:

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, Ipsen Biopharmaceuticals is offering a two-year Medical and Regulatory Affairs PharmD fellowship based in Cambridge, MA.

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:

• 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.

Qualifications:

Doctor of Pharmacy degree from an ACPE accredited institution, eligible for licensure as a pharmacist in the State of Massachusetts.

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.

Additional Information:

Applicants should submit the following APPLICATION MATERIALS by the priority deadline of October 31, 2023

• 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 , 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:

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

Position Type

Research

Additional Information

Northeastern University considers factors such as candidate work experience, education and skills when extending an offer.  

Northeastern has a comprehensive benefits package for benefit eligible employees. This includes medical, vision, dental, paid time off, tuition assistance, wellness & life, retirement- as well as commuting & transportation. Visit https://hr.northeastern.edu/benefits/ for more information.  

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 .