Provides legal advice and support to Commercial, Medical Affairs, Corporate Communications, and Clinical organizations on projects and initiatives related to investigational and approved company products. Substantially participated in design of a comprehensive corporate compliance program to prepare Company for commercialization, specifically by drafting corporate compliance policies and procedures, developing a monitoring plan and processes for investigations, and training company personnel. Focus on Food, Drug, and Cosmetic Act and implementing FDA regulations, fraud and abuse statutes, product liability, antitrust, anti-corruption, reimbursement, and privacy laws.

Member of Pharmaceutical and Biotechnology Practice Group. Provided legal counsel to biotechnology and pharmaceutical companies and other healthcare organizations on government enforcement and regulatory compliance issues. Counseled on a broad range of advertising and promotion issues, including the use of subgroup analyses and pooled data to support promotional claims, disease awareness, healthcare economic claims, comparative claims, responding to unsolicited requests for medical information, scientific exchange, medical field personnel, call plans, speaker programs, publications, and consulting arrangements with healthcare professionals. Also focused on drug safety issues, including risk evaluation and mitigation strategies (REMS) and controlled substances.Representative matters include drafting corporate compliance policies, assisting on a government investigation of a major pharmaceutical company involving alleged off-label promotion, conducting regulatory due diligence for drug company acquisitions, assisting in responding to inspectional observations related to alleged cGMP deficiencies, and drafting comprehensive memoranda for multiple states on each state's regulatory scheme for controlled substances.

Researched, drafted, and otherwise assisted in the development of Citizen Petition responses and FDA Guidance documents.

Delivered oral sales presentations to medical professionals, informing them of the benefits of incorporating ImmunoCAP, a diagnostic allergy test, into their clinical protocol.

Promoted three pharmaceutical products to cardiologists, endocrinologists, and primary care physicians practicing within my sales territory.

Prepared foreign corporation and partnership tax returns, designed tax planning strategies, and developed tax provisions for financial statement reporting purposes.