Novartis is recruiting for an Associate Director / Director of Regulatory Advertising & Promotion Review. This position will be located in East Hanover, New Jersey. This position will be filled at a level commensurate with experience at either an Associate Director or Director level.
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 primary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (“MAP”) teams.
• Liaison with OPDP regarding advertising and promotion issues for assigned products. Establishes strong and positive working relationship with OPDP reviewers.
• Manages OPDP queries on assigned products.
• Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to complex US promotional issues.
• Provides strategic regulatory guidance to Medical Affairs on relevant non-promotional activities.
• Ensures regulatory compliance while effectively managing business risks.
• Understands global promotional strategies and provides solution to local US regulatory promotional issues.
• Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
• Provides training to Novartis representatives responsible for exhibit booth activities at these meetings
• Prepares complaint letters to OPDP.
• Monitors US regulatory promotional environment by reviewing regulatory pro-motional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.
• Provides recommendations to Local Program Teams (“LPTs”) on phase IV clinical trial design with regard to promotability of potential data/claims.
• Provides strategic regulatory guidance to LPTs in the development of draft product labels and Target Commercialization Profile (TCP)s based on global development plans and brand strategic objectives
• Works with US Regional Brand Regulatory Managers on Global Program Teams to insure that regulatory strategy will result in commercially viable US labeling upon which future promotion and advertising will be based.
• Participates in US labeling negotiations and FDA meetings as necessary.
• Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
• 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.
BA/BS Degree, Advanced degree preferable (MS, MD, PhD, PharmD, or JD)
• Minimum 5 years of experience in clinical, regulatory or related experience in the pharma industry
• Excellent understanding of US regulations for drug promotion/advertising and US labeling.
• Experience in the regulatory review of professional and consumer Rx drug advertising and promotion.
• Experience with regulatory activities involved with a product launch.
• Experience in leading activities necessary for promotional OPDP submissions (including pre-clearance and 2253, “time of first use” submissions).
• Strong understanding of business goals of the involved business franchise, marketing concepts and tools.
• Must perform independently with strong problem solving, negotiation and decision making skills.
• Must possess strong interpersonal and communication skills.
Website : https://www.sandoz.com/
Sandoz prides itself on thinking differently. While developing and manufacturing high-quality affordable medicines is core to who we are and what we do, our mission is even greater: We endeavor to make these medicines available to everyone, everywhere. Our portfolio of approximately 1 000 molecules is already available to more than 90% of the world’s population and we continue to work hard to further increase global access.