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Fellow - Regulatory Affairs Advertising and Promotion

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 Physical Requirements 10%-15% overnight travel required. Qualifications A Doctor of Pharmacy degree from an Accreditation Council for Pharmacy Education (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
Salary Range: NA
Minimum Qualification
Not Specified years

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