Rare combination of a board-certified physician who served as Vice President of Global Regulatory Affairs and Chief Medical Officer for a global pharmaceutical company. I approach work from all three perspectives, leading to insightful solutions for complex problems. Launch Planning: Preparations for the successful launch of pharmaceutical products, including publication planning, Key Opinion Leader identification and engagement, post marketing clinical trial strategy development, Medical Information systems, and Medical Science Liaison development and deployment.Drug Safety: Design of drug safety collection and assessment systems that are scaled to the client’s needs, sourcing of strategic vendors to drive quality at a sustainable cost, and development of effective and rational safety signaling processes. Pharmacovigilance: Independent assessment of a drug product's risk/benefit profile and the development of appropriate and reasonable risk mitigation strategies. Design systematic methods for the early identification of new safety information. Devise relevant drug safety communication strategies targeting regulatory authorities, prescribers, payers and patients. Create REMS systems that drive safety in a cost-effective manner.Regulatory Affairs: Develop communication strategies and author submission documents intended to inform regulatory authorities of the clinical context surrounding particular drug safety information. Assists with regulatory authority interactions for product approvals including preparations for Advisory Committees. Devise response strategies for Warning Letters or other regulatory authority enforcement actions.BD&L: Assist in identifying potential Business Development opportunities and the subsequent evaluation of pivotal clinical data or proposed product claims.