Associate General Counsel
Tel-Aviv, Il
Managed risk exposure and litigation at this global pharmaceutical firm associated with commercial and IP disputes, product liability and clinical trials involving innovative and generic drugs. Counseled R&D, regulatory, medical/scientific and pharmacovigilance executive board as well as quality and technical operations committee to manage emerging regulatory, compliance, and safety risks involving labeling and promotional practices, recalls, clinical trials and post-marketing safety obligations. Counseled commercial, corporate communications, environmental, insurance, and information record units. Negotiated and resolved commercial disputes involving research and development, supply and distribution, and breach of patent settlements. • Investigated and favorably settled for $27.6 million DOJ criminal and civil investigation of Company’s promotional practices and compliance with FDA regulations and fraud and abuse laws with no criminal charges filed.• Developed risk management training and education for internal corporate communications.• Implemented and refined litigation hold, and record and information management policies and program.• Developed global product liability risk mitigation initiative in coordination with Company enterprise risk management program.• Managed regulatory and labeling strategy with foreign health authorities regarding reanalysis of adverse event data.• Led and successfully resolved international litigation, regulatory, IP, commercial, compliance, governance, communications, and employment issues arising out of Company’s multi-billion dollar acquisition of a foreign pharmaceutical company.• In matter associated with regulatory issues re toxicology classification of oncology drug, successfully recovered $55 million in UK courts dispute with contract manufacturer. • Led and successfully recovered $340 million in 10 highly contested London arbitrations involving damages from patent infringement.