Regulatory Data Assessment Analyst researching regulatory compliance for financial services at Truist Bank. Collaborating with stakeholders to validate data quality and enhance testing processes.
About the role
- 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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