Application Deadline: Wednesday, November 10th @ 11:59PM ET.
*Please note that to be considered for this Fellowship, you must apply directly to the position's posting on the Novo Nordisk website at novonordisk-us.com
About the Department
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 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 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 (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 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.
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
Advertising and Promotion
Ensure company compliance with Food & Drug Administration (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 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
5% - 10% overnight travel required
A Doctor of Pharmacy degree from an ACPE-accredited College of Pharmacy with strong academic track record required
Demonstrated leadership capabilities
Presentable, highly articulate, goal-oriented, honest, with high integrity and strong ethics
Track record of team work, innovation and project management
Ability to think critically, strategically, and independently
Possess good communication skills, both oral, written and presentation
Demonstrate an ability to perform medical accuracy review with strong attention to detail
Proficiency in PowerPoint, Excel and MS word software applications and overall computer skills with knowledge of literature search technique required
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 43,000 people in 80 offices around the world, and market our products in 170 countries.
For almost 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 today is not necessarily what will make us successful in the future. As an employer, we recognise 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.