In This Section
- Medical Information/ Medical Affairs — Johnson & Johnson Consumer Inc.
- Medical Information and Payer/Health System — Janssen Scientific Affairs
- Medical Information/ Medical Affairs — CSL Behring
- Multidisciplinary — Genmab US, Inc.
- Global Regulatory Affairs — Kyowa Kirin Pharmaceutical Development, Inc.
- Biologics Product Development & Investigational Drug Trial Design and Management — Janssen Research and Development
- Fellowship Alumni
- Eligibility and Application Process
The fellowship will include elements of medical information, medical affairs and congress planning.
Genmab US, Inc
Genmab US, Inc. is an international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.
In 2019, Genmab partnered with University of the Sciences to offer a unique one-year Fellowship in Global Medical Affairs. Genmab is expanding the Fellowship to two years and offering an opportunity to gain experience across three functional areas: Global Medical Affairs, Global Regulatory Affairs, and Clinical Development.
This Fellowship provides the Fellow an opportunity to be involved in pre-launch, launch, and post-launch activities across multiple functions with mentoring from experienced preceptors.
View our Genmab Fellowship Brochure (PDF)
The four 6-month multidisciplinary rotations include Global Medical Affairs, Global Regulatory Affairs, Clinical Development, and an Elective*.
*Fellows will have the opportunity to gain a deeper understanding in one of the functional areas for an additional 6 months.
Global Medical Affairs
- Understand the role and responsibilities of a Global Medical Information professional in the pharmaceutical industry
- Provide timely and balanced responses to Genmab external customers
- Create and maintain a database of Global Medical Information responses, including consistently evaluating opportunities to innovate the content format
- Provide high quality review of Promotional and Scientific Exchange Materials to ensure accuracy and appropriateness of content
- Attend scientific congresses to provide support for Medical booths
- Gather insights to identify communication needs or data gaps to drive Medical Strategy
- Gain therapeutic proficiency of products within the Oncology Portfolio
- Develop a global strategic publication plan collaborating closely with key stakeholders including Medical Strategy, Statistics, Medical Research Team, and Senior Leaders
- Develop familiarity with publication principles and participate in the development of a publication deliverable (e.g. congress presentation, manuscript)
- Assess and identify gaps with Field Medical Resources, collaborating with Medical Affairs Strategy Leads, Field Medical and vendors to create and revise Field Medical resources, including slide decks, frequently asked questions (FAQs) and training materials
- Understand the congress planning process from identifying key sessions to developing summaries following conclusion of the meeting while collaborating with large cross-matrix team
- Organize pre-congress training and dissemination of information
- Contribute to the development of Scientific content for the Medical Affairs congress booth
Global Regulatory Affairs
- Develop understanding of global regulations and guidances related to drug development
- Support cross-functional product teams by offering expertise and strategic guidance on regulatory requirements for global drug development and market registrations
- File and maintain Investigational New Drug Applications (INDAs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs) and Clinical Trial Applications (CTAs)
- Acquire a working knowledge of international and country-specific requirements to support the conduct of global clinical studies
- Gain understanding on how to best conduct health authority meetings and prepare teams for effective regulatory interactions
- Interface with internal and external stakeholders to ensure company compliance with all appropriate regulations and guidances
- Collaborate cross-functionally with global colleagues and scientists, representing diverse backgrounds, knowledge, and expertise
- Gain knowledge in Translational Medicine and Pharmacokinetics concepts, and clinical regulations, including International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP) requirements
- Achieve proficiency in understanding clinical research protocol(s)
- Develop technical writing skills by creating a mock abbreviated protocol
- Support study execution by understanding the process of investigator calls, evaluating escalation of clinical questions and clinical data querying
Rachel No, PharmD
University of Michigan, Class of 2020
Global Medical Affairs Fellow
Director, Industry and Education Fellowship Programs
600 South 43rd Street
Philadelphia, PA 19104-4495