Counsel/senior Counsel Healthcare Compliance

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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.

Company info

Rhythm Pharmaceuticals, Inc.
222 Berkeley Street, 12th Floor
Boston
Massachusetts
United States 02116
Website : https://www.rhythmtx.com/