Associate Director / Director , Regulatory Advertising and Promotions job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us 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.|
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.
This position provides strategic regulatory advice on advertising and promotion materials and activities for assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy.
• 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%).Position will be filled at level commensurate with experience.
BA/BS Degree required, 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.