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 Doctors of Pharmacy within the pharmaceutical industry. The postdoctoral fellow will focus on Regulatory Affairs Advertising and Promotion at Novo Nordisk Inc., where a PharmD’s training and expertise will provide value to the organization. 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 customer needs and achieving company goals.
As part of this 1 year fellowship, the fellow will gain experience in Regulatory Affairs 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 (PRB) meetings. The fellow will be selected on a nationally competitive basis.
Relationships The fellow will report to their Fellowship Manager/preceptor within Regulatory Affairs – Advertising and Promotion throughout the one-year program. Additional key internal relationships include other areas of Regulatory Affairs. External relationships include interaction with FDA personnel regarding assigned projects and roles.
Essential Functions General
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 Affairs, Medical 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
Advertising and Promotion
Ensure company compliance with FDA and Federal Trade Commission (FTC) requirements, including 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. Assist in establishing procedures to assure compliance with these requirements
Review draft and final advertising/promotional materials to ensure regulatory compliance of all materials for assigned products
Assist in development and implementation of strategy to maintain efficient and compliant promotional review and submission processes
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Employer will assist with relocation costs.
Internal Number: 58769BR
About Novo Nordisk Inc.
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.