Counsel/senior Counsel, Healthcare Compliance Counsel Jobs in Massachusetts - 171505 | Submit Resume | General Counsel Consulting
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Counsel/senior Counsel, Healthcare Compliance
Refer job# UQIT171505
 
Counsel/Senior Counsel, Healthcare Compliance The candidate will take primary responsibility for maintaining and enhancing the company's healthcare compliance program, including establishing policies and procedures and providing appropriate guidance, training, and monitoring to ensure compliance with federal, state, and local laws and regulations. Act as the legal counsel to internal clients on FDA/EMA laws and regulations, fraud and abuse laws and regulations, reporting transfers of value in compliance with financial transparency laws, HIPAA/GDPR/privacy and other relevant laws and regulations governing the development and commercialization of pharmaceutical products in the US, EU, and international jurisdictions. Provide advice and counsel to clients on the Anti-Kickback Statue, False Claims Act, PhRMA Code and FDA regulations in connection with product labeling, promotional activities, marketing strategies, sales training and compensation, speaker bureaus, and communications with FDA. Review and provide legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations. Review, analyze and advise on matters related to reimbursement activities, access services, patient support and assistance programs, government coding and reimbursement, payment and coverage decisions. Advise internal clients with respect to projects, initiatives, and communications regarding approved products and indications as well as those pending FDA approval, including participating on the promotional review committee. Proactively identify legal and compliance risks and work with other internal stakeholders to effectively eliminate or mitigate those risks while concurrently supporting business strategic goals. Manage outside counsel and external compliance partners as needed in connection with executing the above responsibilities and duties.

The candidate should have a BA/BS degree. JD from accredited law school and license to practice in at least one US jurisdiction. Should have 5+ years of experience as a practicing attorney, with at least 3 years of experience advising the pharmaceutical/biotech industry. Have worked at a leading U.S. national law firm and/or had an in-house counsel position with a leading biotech/pharmaceutical company with significant marketed products. Experience with rare diseases is a plus. Significant legal experience in fraud and abuse counseling, privacy, and FDA issues, with a strong understanding of the OIG's Guidance for the Pharmaceutical Industry, applicable regulations and laws relating to the development, sales and marketing of pharmaceutical products, and the current federal and state enforcement landscape. Experience with laws and regulations governing genetic testing is a plus. Experience with EU and international laws and regulations governing pharmaceutical/biotech products is a plus. Excellent interpersonal communication and negotiation skills, including both oral and written communication skills. Ability to independently manage workload in a fast-paced environment. Ability to provide practical, timely, and risk-appropriate legal counsel to a wide variety of internal clients on legal and regulatory matters and interact effectively with employees at all levels of the organization.
 
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