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Associate Director : Regulatory Affairs : AD Promo
Location:
Princeton, NJ
Description:
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 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 Associate Director, Regulatory Affairs : Advertising and Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidances, and company policies. Relationships Develop and maintain positive rapport and working relationships with Regulatory Affairs, Legal, Commercial, and other cross:functional stakeholders to accomplish company goals. Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs : Advertising and Promotion. Essential Functions stylemargin:bottom:11.0px::Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape:Assess risk and advise on mitigation strategies to meet overall business need, while maintaining compliance with US regulatory requirements and company operating procedures:Maintain up:to:date knowledge of laws, regulations, and policies enforced by Federal and State governments as they relate to advertising and promotion of pharmaceuticals and devices:Apply regulatory and therapeutic area knowledge to Brand Team's objectives and initiatives to develop solutions to promotional issues, while ensuring regulatory compliance and effectively managing business risks:Creatively advise on the development of product messages and materials across multiple functional areas, and propose regulatory strategy and solutions to challenging promotional concepts that meet business objectives:Provide training in FDA regulations for advertising and promotion to employees and agents of Novo Nordisk:Collaborate with Regulatory Affairs colleagues to provide input to study designs or US labels regarding feasibility of promoting potential data/claims with manager oversight:Participate/assist in US labeling negotiations as necessary. Ensure that changes in US Prescribing Information are reflected in current promotion and advertising in a timely manner:Play a critical role in pre:launch and launch activities as necessary, including the development of launch materials/new claims by collaborating with Commercial, Medical and Legal:Advise in the development and implementation of strategies to maintain efficient and compliant Promotional Review Board (PRB) process:Serve as a primary regulatory advertising and promotion reviewer for assigned products:Liaison with OPDP regarding advertising and promotion for assigned products. Oversees preparation and submission of draft introductory materials to OPDP for advisory comment:Ensure company compliance with FDA requirements, including timely and accurate submission of advertising and promotional materials to OPDP with FDA Form 2253 Physical Requirements 0:10 overnight travel required. Flexible. Qualifications stylemargin:bottom:11.0px::A Bachelor's degree required; life science and advanced degree preferred:A minimum of 7 years of experience in pharma
Posted:
May 9 on Tip Top Job
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More About this Listing: Associate Director : Regulatory Affairs : AD Promo
Associate Director : Regulatory Affairs : AD Promo is a Executive Associate Director Job located in Princeton NJ. Find other listings like Associate Director : Regulatory Affairs : AD Promo by searching Oodle for Executive Associate Director Jobs.
Associate Director : Regulatory Affairs : AD Promo is a Executive Associate Director Job located in Princeton NJ. Find other listings like Associate Director : Regulatory Affairs : AD Promo by searching Oodle for Executive Associate Director Jobs.