Compliance Counsel The candidate will provide sound compliance guidance to employees of company, consistent with applicable laws, regulations and policies. Conduct and manage compliance investigations regarding allegations of potential violations of law or company policy and/or ethical standards, prepare reports on the results of the investigations, and assist with the determination and implementation of corrective actions. Conduct monitoring and auditing to ensure compliance with applicable laws, regulations and policies, including field rides, speaker programs and advisory boards. Analyze monitoring and auditing results to recommend improvements in compliance or business operations. Assess compliance training needs, develop and deliver effective and creative training, including written materials, computer-based training and live presentations. Provide compliance input and expertise into business decisions, including development of solutions-orientated risk mitigation strategies. Perform other duties as assigned/requested.
The candidate should have BA/BS and JD, Should have 3+ years of experience in the biotech/pharmaceutical or medical device industry. In depth understanding of the Anti-Kickback Statute, the False Claims Act, Federal Food, Drug, Cosmetic Act; PhRMA Code; OIG Seven Elements; HIPAA; and federal and state transparency and disclosure laws; Strong knowledge of industry compliance best practices, regulatory landscape, and pharmaceutical compliance training and monitoring programs. Excellent verbal and written communications skills; must be an effective communicator with strong interpersonal skills. Ability to establish and maintain relationships across multiple corporate functions.
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