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Vice President, Senior Counsel, Compliance
Refer job# IOOT145054
 
Vice President, Senior Counsel, Compliance RESPONSIBILITIES: Serving as the lead attorney/legal advisor for one or more brands/business functions by providing legal advice and counseling on FDA labeling, marketing strategies, promotional tactics and materials, direct-to-consumer advertising campaigns and programs, healthcare fraud and abuse laws, anti-kickback statute and other laws impacting the commercialization of pharmaceutical products in the U.S.; Counseling colleagues on appropriate relationships with healthcare professionals, patients, managed care entities, healthcare organizations, and government officials and entities; Drafting, reviewing, and negotiating legal documents, including contracts; Interacting with external counsel, advisors, external vendors, and business partners; Working collaboratively and creatively with internal clients by clearly and effectively rendering practical and timely legal advice on complex issues/concepts; Advising on the interpretation of legal documents and applicable laws and regulations in a manner that provides practical legal advice while properly managing risk to the organization; Developing and maintaining a Corporate Compliance Program, including drafting and reviewing policies, developing and providing training to all employees, establishing a monitoring system as needed, and investigating and maintaining records for employee investigations; Ensure all data protection and data privacy requirements are met; Ensure all transparency reporting laws are complied with, including the Federal Sunshine Act; With the General Counsel and other Executive Leadership Team members, help develop a Company risk management program; Leading special projects as assigned and participating in cross-functional teams and committees while demonstrating leadership ability to colleagues and business partners; Working closely with other members in the Legal Department to ensure consistency in approach across areas of the overall business and providing support for areas outside of his/her primary areas of responsibility as needed; and Keeping informed of new laws, regulations, and industry trends affecting the organization, and assisting with development of policies and training as needed.

Qualifications: JD Degree and active law license required (California preferred). 15 years combined experience in-house and with a law firm; Significant knowledge of and experience advising clients on laws and regulations governing the pharmaceutical industry, including but not limited to FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, and product liability laws; Demonstrated experience drafting legal documents, including contracts; Ability to effectively deliver oral presentations, train, and educate colleagues on legal topics and issues; Self-motivated, innovative, strategic, and detail-oriented; Ability to analyze complex legal issues and deliver solutions-oriented legal advice and options in a way that can be understood by non-lawyers; Excellent judgment, strong influencing/negotiation skills, and leadership ability; Ability to manage multiple projects, remain organized, and work successfully in a fast-paced environment; and Excellent communication skills both oral and written, ability to work independently with little supervision, ability to handle heavy workload for multiple clients, and a team player with strong interpersonal skills.
 
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