The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk 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 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 Regulatory Affairs Therapeutic Area 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 with a focus on Regulatory Affairs for prescription drugs and devices at Novo Nordisk Inc. (NNI). 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 the Therapeutic Area with a track for experience in Advertising and Promotion. The fellow will learn about FDA regulations, including compilation and submission of any required documents to FDA.
The fellow will report to their Fellowship Manager/preceptor within the Regulatory Affairs – Therapeutic Area team throughout the one-year program. Additional key internal relationships include global and US stakeholders in other areas of Regulatory Affairs, as well as those who are part of 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: Commercial, Safety, Medical, Clinical Operations, and Legal. 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
Assist in preparation of regulatory documents
Work with global stakeholders from headquarters on preparation of submissions to FDA
Assist in review or development of labeling for marketed products and new products as assigned
Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents
Prepare and compile content plans for submissions to an investigational or marketing application in accordance with applicable SOPs and FDA regulations/guidances
Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions
Advertising and Promotion track
Ensure company compliance with FDA and 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 ensure 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
We are a global healthcare company, founded in 1923 and headquartered just outside Copenhagen, Denmark with our US headquarters located in Plainsboro, NJ. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity, and rare blood and rare endocrine diseases. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat. We employ more than 55,000 people in 80 offices around the world.
For over 100 years, we have been translating the unmet medical needs of people living with a serious chronic disease into innovative medicines and delivery systems, like our insulin pens. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Our industry is dynamic. And the scientific understanding of the diseases we treat and the people living with them, improves every day. This is a constant reminder that what got us to where we are t...oday is not necessarily what will make us successful in the future. As an employer, we recognize the need to embrace experimentation and strive f or diversity and inclusion to help make better decisions by ensuring that multiple perspectives are considered. Together, we’re life changing.