About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk Inc (NNI) is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the Food & Drug Administration (FDA) to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?
The Position The Regulatory Affairs Advertising and Promotion Postdoctoral Fellowship is a one-year, experiential program based in Plainsboro, New Jersey. This fellowship is intended to provide experience for Doctor of Pharmacy within the pharmaceutical industry with a focus on Advertising and Promotion for prescription drugs and devices at Novo Nordisk Inc. The fellow will gain the skills needed to pursue a career within the pharmaceutical industry where their education and experience can make a significant contribution to satisfying business needs and achieving company goals.
As part of this one-year fellowship, the fellow will gain experience in Regulatory Affairs, specifically in Advertising and Promotion. The postdoctoral fellow will learn about compliance with internal policies and Federal and State regulations, including compilation and submission of any required documents to regulatory agencies. As fundamentals are established, the fellow will review advertising and promotional materials and participate in Promotional Review Board meetings.
Relationships The fellow will report to their Fellowship Manager/preceptor within the Regulatory Affairs – Advertising and Promotion team throughout the one-year program. Additional key internal relationships include other areas of Regulatory Affairs and stakeholders in the promotional review process. External relationships include potential interaction with FDA personnel regarding assigned projects and roles.
All fellows will complete a Fellowship project for presentation at a key conference/congress. Additionally, fellows may be asked to attend other relevant scientific conventions, regulatory conferences, and other travel as required for business needs related to fellow projects
The fellow will have regular contact with cross functional areas including: Marketing, Medical Information, Marketing Operations, and Legal Affairs. This structured approach will allow for a broad, “hands-on” experience enabling the fellow to gain the skills needed to pursue a career within the pharmaceutical industry
Ensure company compliance with FDA and Federal Trade Commission (FTC) requirements, including review of draft and final advertising and promotional materials for assigned projects, and timely and accurate submission of promotional materials to FDA on Form 2253
Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices. Advise appropriate departments within the company of these requirements and assist in establishing procedures to assure compliance with these requirements
Monitor the prescription drug advertising and promotion landscape and competitor promotional materials to provide regulatory intelligence to relevant stakeholders
Assist in development and implementation of strategy to maintain efficient and compliant promotional review and submission processes
Novo Nordisk A/S is a global healthcare company with more than 90 years of innovation and leadership in diabetes research, care and treatment.
This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions such as hemophilia, growth disorders and obesity.
Established in 1923 and headquartered in Copenhagen, Denmark, Novo Nordisk employs approximately 43,100 people in 79 countries and markets its products in more than 170 countries.
Novo Nordisk, Inc., is the US affiliate of Novo Nordisk A/S. Our US headquarters are located in Plainsboro, NJ, and the Novo Nordisk US business presence stretches from coast to coast -- from an insulin manufacturing plant in North Carolina to the Novo Nordisk Research Center in Seattle, WA.