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Years of Experience
Date Last Verified
Director, Senior Counsel - Healthcare, Regulatory and Commercial The candidate will provide company managed markets team with advice about, and assist in drafting and negotiating contracts for, commercial, Medicare Part D, government contracts, and trade/distribution contracts. Provide advice and guidance on issues pertaining to best price, AMP, ASP, and government price reporting. Serve as a member of company's Pricing Committee. Serve as a subject matter expert in areas of healthcare regulatory law, including rules and regulations of the FDA, OIG and CMS and applicable anti-kickback, privacy, fraud and abuse, anti-bribery and product liability statutes and regulations. Serve as the legal representative on promotional materials review committee, and provide legal review of sales training materials, corporate communications, etc. Provide advice on market access initiatives and patient assistance programs. Participate as the legal representative on other commercial and medical scientific affairs committees on an as-needed basis. Assist and advise in the conduct of internal investigations. Stay abreast of and communicate to the organization significant legal developments, legislation and regulatory rulings that may affect the company in the area of commercial healthcare law. Establish a strong rapport and a positive working relationship with associates at all levels, particularly within the home office and field-based Commercial and Medical Scientific Affairs organizations. Respond to questions from the research and development organization on an as-needed basis, including questions related to conduct of clinical trials in the United States and abroad. Supervise external legal counsel.
Qualification and Experience
The candidate should have a J.D. degree from a law school accredited by the ABA. Must have 7+ years of related experience within a commercial stage pharmaceutical company or law firm equivalent, with a focus on commercial legal support activities. Should be admitted to practice law in one or more states. Experience with managed care contracting is required. Expertise in the areas of corporate compliance, commercial healthcare, and FDA regulatory law and regulation, including with respect to FDA labeling and promotional matters, healthcare fraud and abuse laws, privacy laws, anti-bribery laws, and other laws and regulations related to the development and commercialization of pharmaceutical products is needed. Large law firm and in house experience is preferred.
Job ID: 1410
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