Novartis is recruiting for an Associate Director / Director of Regulatory Advertising & Promotion Review. This position will be located in East Hanover, New Jersey. An Associate Director candidate is being sought, but the position will be filled at a level commensurate with experience.
A global healthcare leader, Novartis, has one of the most exciting product pipelines in the industry today. It is a pipeline of innovative medicines brought to life by diverse, talented, and performance driven people. All of this makes Novartis one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
The core responsibilities for this role include the following:
Serves as a regulatory reviewer for assigned products/Franchise. Ensures regulatory compliance while effectively managing business risks.
Ensures that strategic regulatory advice is provided on advertising and promotion materials/activities for assigned products in accordance with business goals and objectives, FDA regulations and guidances, PhRMA guidelines and company policy.
Reviews relevant medical and clinical development non-promotional materials in accordance with company policies.
May provide strategic regulatory advice and guidance as a member of the Franchise Governance Board.
Directs the activities of regulatory personnel responsible for submission of promotional materials to FDA
Engages in onboarding new hires, junior colleagues, fellows and interns within the DRA A&P group and may offer training/mentoring/coaching to these individuals.
Represents DRA A&P on internal, cross-functional, cross divisional initiatives relevant to promotion of prescription products in the US.
Primary liaison with OPDP regarding advertising and promotion for Franchise products, including authoring responses to OPDP letters and complaint letters to OPDP.
Maintains awareness of competitive activities by monitoring major US Medical meetings. Ensures the regulatory training of Novartis representatives responsible for exhibit booth activities at these meetings.
Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance at major FDLI, DIA, and other industry/FDA meetings (when appropriate).
Provides strategic input into the development of product labeling to maximize opportunities to support promotional activities.
Travel may be required based on business needs (10%).
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Position will be filled at level commensurate with experience.
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.