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Senior Director, Corporate Compliance And Healthcare Counsel
Refer job# OMKR146235
Senior Director, Corporate Compliance and Healthcare Counsel The candidate reports to the Chief Compliance Officer. The position includes management and oversight of the Companys Corporate Compliance Program, with significant interaction with companys Sales and Marketing, Legal, Information Technology, Business Development, Medical Scientific Affairs, and Research and Development, and other company departments. Will work to maintain, and continue to enhance, companys culture of embracing compliant practices and behaviors through close collaboration with internal and external business partners. In addition, this position will provide companys Sales and Marketing team with brand and managed markets advice and counsel providing advice and counsel. Responsibilities: Partner with company departments to maintain a company culture that embraces compliance and recognizes that compliance is a collective responsibility of all company employees; Increase awareness of the importance of the corporate compliance program, and maintaining and expanding visibility of the corporate compliance program throughout company; provide general guidance to the business and integrate compliance controls into the scope of existing business practices company-wide; Develop, implement, maintain and regularly assess key policies and procedures to mitigate identified risks and to meet government, industry and company compliance requirements; Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state fraud and abuse and anti-kickback statutes, government price reporting laws, OIG and PhRMA guidelines, state marketing compliance laws; Provide oversight and guidance to department members regarding obligations and submissions federal and state authorities regarding applicable transparency ( Sunshine ) laws; Maintain current working knowledge of, and develop and implement policies regarding, evolving federal and state privacy laws; Develop, maintain, enhance and administer effective compliance training programs through various delivery formats that focus on the elements of the compliance program and seek to ensure that appropriate employees understand, and understand the importance of compliance with, pertinent requirements; Collaborate with Company management and other personnel to identify and provide ongoing risk assessment of existing and emerging business practices for potential areas of compliance vulnerability, and develop/implement preventive active plans to help maintain compliance, and where necessary develop and implements corrective action plans for the resolution of issues; Provide regular updates and reports to the Chief Compliance Officer, the Compliance Committee, and senior and executive management on the operation and progress of compliance efforts and initiatives, audit findings, investigation outcomes, and project status updates; Oversee and implement compliance-related auditing and monitoring plans for sales, marketing and other business activities; Assist in management of compliance investigations involving potential violations of compliance policies, laws or regulations and overseeing corrective action; 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; 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 companys Pricing Committee.

The candidate should have J.D. from a law school accredited by the American Bar Association (ABA). Must be admitted to practice law in one or more states. 8 10 years of pharmaceutical company compliance experience is required. Must have expertise in the area of pharmaceutical industry corporate compliance with a proven record of accomplishment in the areas of drafting and implementing compliance policies, training, auditing, monitoring, and investigations. Must have knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, state marketing compliance laws, the Foreign Corrupt Practices Act, the UK Bribery Act, and other anti-bribery laws. Should have expertise in commercial healthcare, and FDA regulatory law and regulations, including expertise in FDA labeling and promotional requirements, healthcare fraud and abuse laws, privacy laws, anti-bribery laws, and other laws and regulations related to the development and commercialization of pharmaceutical products.
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