Attorney with an entrepreneurial mindset and a global perspective who achieves success using strategic and analytical problem solving strategies, combined with technical knowledge and organizational skills, to support pharmaceutical, biologics, biotech and medical device product development, manufacturing and marketing, Expertise includes: Counsel on research and development, animal research, clinical trials, manufacturing/cGMP, labeling, advertising/promotion, social media, distribution, Health Economics and Outcomes Research (“HEOR”) and new product launches  Advise on U.S. Food and Drug Administration (“FDA”), Drug Enforcement Administration (“DEA”), European Medicines Agency, privacy/HIPAA, IRB, PhRMA Code, anti-kickback, OIG/fraud and abuse, Sunshine Act, PDMA/drug sampling, recalls, due diligence, products liability, and risk management issues  Negotiate, draft and review domestic and international agreements  Design and implement compliance programs and conduct audits, monitoring activities, and investigations Present basic and advanced training programs to Law, Sales and Marketing, Medical, Regulatory Affairs, Quality Assurance, and Corporate Communications Department