Genmab US, Inc.

Multidisciplinary Fellowship

Location: Plainsboro, NJ
Recruiting: 2 Positions for a 2-Year Fellowship

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 Philadelphia College of Pharmacy to offer a unique one-year Fellowship in Global Medical Affairs. In 2021, Genmab expanded the program to a two-year Multidisciplinary Fellowship 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.

Multidisciplinary Rotations

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

Medical Information

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.

Medical Communication

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.

Congress Planning

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), Biologic License Applications (BLAs), 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.
Support the labeling team with creating and maintaining competitive and up-to-date labeling documents.

Clinical Development

Gain insight into various phases of clinical development during a drug’s life-cycle (ie, study start-up through submission, including analysis and publication) as well as building knowledge within the therapeutic area and disease indications.
Develop technical writing skills by participating in authoring clinical documents such as study protocols, patient informed consents, and charters.
Achieve proficiency in understanding clinical research protocols and applying concepts to addressing investigator site questions.
Monitoring patient clinical data to monitor safety and efficacy.
Develop relevant slide decks with opportunity to present to the internal/external Genmab team as well as trial investigators (PIs and sub-Is) and key opinion leaders (KOLs).
Exposure to Translational Medicine and Pharmacokinetics concepts, Clinical Operations/CRO, Safety, Medical Communications and the Publication Preparation/Plan(s), Medical Writing, Biostats, Data Management, Program Management/CDT, external collaborators and Key Opinion Leaders, and clinical regulations, including International Council for Harmonisation of Technical. Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and Good Clinical Practice (GCP) requirements.