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.
This is a 2-year post-graduate training program providing advanced skill training in a variety of functions, including Global Medical Affairs, Clinical Development and Regulatory Affairs.
This fellowship prepares individuals to pursue a career in the pharmaceutical industry.
Weekly responsibilities are split between USciences (20%) and Genmab (80%).
The fellow will rotate between Global Medical Affairs, Regulatory Affairs, Clinical Development and a rotation of the fellow’s choosing (6 months each).
The fellow will successfully complete projects related to industry, the fellowship program, and teaching responsibilities.
It is expected that as the fellow progresses through the program, the individual will be able to practice with increasing levels of independence.
Develop and cultivate core skills and competencies in analytical reasoning, critical and strategic thinking, problem solving, communication, influencing, and teamwork.
Develop professional responsibility and enhance leadership presence.
Enhance interpersonal communications with healthcare providers, strategic business partners, and consumers.
Strengthen ability to critically evaluate, interpret, synthesize, and communicate scientific information.
Instill knowledge of laws, compliance regulations, and guidance’s pertaining to medical and regulatory affairs
Advance critical thinking skills through industry-based projects and cross-functional teamwork.
Strengthen leadership and professionalism through participation in academic and industry initiatives.
Apply and communicate clinical knowledge to projects and project teams.
Global Medical Affairs
Develop an understanding of the role and responsibilities of a Medical Information professional in the pharmaceutical industry
Provide timely and balanced responses to Genmab external customers
Create and maintain a database of 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 received by Medical Information to identify communication needs or data gaps to drive Medical Strategy
Gain therapeutic proficiency of products within the assigned therapeutic area 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 (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 comprehensive understanding of global regulations and guidance 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 thorough understanding on how to best conduct health authority meetings (including advisory committee meetings) and prepare teams for effective regulatory interactions
Interface with internal and external stakeholders to ensure company compliance with all appropriate federal regulations and guidance documents
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
Appointment to Clinical Instructor in Pharmacy Practice
Completion of a one-year teaching certificate program with responsibilities for didactic and experiential teaching and a continuing education (CE) presentation for pharmacists
Actively participate in professional development seminars and workshops designed to enhance professional growth and leadership
Contribute to the successful functioning of the fellowship program, such as facilitating student outreach, recruitment, marketing, social media, team building, etc.
BENEFITS AND COMPENSATION
USciences provides a competitive bi-weekly stipend and a comprehensive benefits package, including the option to enroll, tuition-free, in one of the University's online degree and certificate programs: MBA Pharma/Healthcare or Biomedical Writing.
PPS Interview Request
Interested candidates should submit a request for an interview through the PPS portal with a CV and a letter of intent. Candidates selected for a PPS interview will be notified by email with the interview date & time.
Online Application Portal
Candidates must complete an online application through the USciences Application Portalby December 2, 2020. Please submit the following items electronically through the application portal or via mail/email to the address listed below:
Letter of Intent
Three (3) letters of recommendation (sent to the email below)
Writing sample (drug information response is preferred)
Unofficial transcript(s) for all college coursework
Emailed to the following:
James M. Hollands, PharmD, BCPS Fellowship Director PCP/USciences Mailbox 34 600 S. 43rd Street Philadelphia, PA 19104-4495 Pharmafellows@usciences.edu
Computer skills: Microsoft Office, email and calendar proficiency
Sufficient technology aptitude to learn new technology systems, including virtual conferencing if necessary
Medical writing proficiency
Communication skills, including formal presentations
Ability to work cross-functionally with a diverse team
Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy (by the start of the fellowship program)
The fellow will be required to split their time between the university and the industry site, currently located in Plainsboro, NJ, approximately 50 miles from the university.
About Genmab US & University of the Sciences
Philadelphia College of Pharmacy is the first pharmacy school in the nation and part of the University of the Sciences. The Department of Pharmacy Practice and Pharmacy Administration is dedicated to educating students in pharmacy, conducting research, and performing service to advance the University, the profession, and society.