The Regulatory Affairs Promotional Review 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 Promotional Review at Novo Nordisk Inc., where a Pharm.D.’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 Promotional 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.
The fellow will report to their Fellowship Manager/preceptor within Regulatory Affairs – Promotional Review 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.
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, national team meetings 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. 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.
Assure company compliance with FDA and FTC requirements and strategy, including: timely and accurate submission of promotional materials to FDA in 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 assuring full regulatory compliance of all promotions for all assigned products.
Assist in development and implementation of strategy to maintain efficient and compliant PRB process.
Ability to drive or to fly to various meetings - approximately 15% overnight travel.
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
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
Novo Nordisk: Collaborates Across Boundaries
Novo Nordisk: Drives Performance
Novo Nordisk: Fosters Innovation and Continuous Improvement
Located in Plainsboro, New Jersey, Novo Nordisk Inc.’s North American business has approximately 5,000 employees nationwide handling sales, marketing, medical,
managed care, trade and government activities. As a world leader in diabetes care, Novo Nordisk has its headquarters in Denmark, employs over 40,000 employees in 80 countries and markets its products in 179 countries. In addition, Novo Nor...disk has a leading position within areas such as hemostasis care, growth hormone therapy and hormone therapy.