Senior Manager, Regulatory Ad Promo at Novartis providing strategic regulatory advice on advertising/promotion for US products. Overseeing advertising compliance and ensuring regulatory standards are met.
Responsibilities
Provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products
Serve as a primary or secondary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (“MAP”) teams
Liaison with OPDP regarding advertising and promotion for assigned products
Ensure regulatory compliance while effectively managing business risks
Maintain awareness of competitive activities by monitoring major US Medical meetings
Collaborate with Regulatory Development colleagues to provide input to study designs or US label
Participate/assist in US labeling negotiations and FDA meetings as necessary
Requirements
BS Degree or equivalent
Advanced degree desirable (MS, PhD, PharmD, or JD)
Knowledge of drug development process
Ability to analyze and interpret efficacy and safety data desired
Understanding of business goals of the involved business franchise, marketing concepts and tools
Must be able to work in a multi-disciplinary environment
Must process strong interpersonal and communication skills
Must have analytical and problem-solving skills associated with problem review and inquiries
Must be able to provide creative solutions to problems.
Benefits
health insurance
life and disability benefits
401(k) with company contribution and match
generous time off package including vacation, personal days, holidays and other leaves
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