Corporate Counsel US Market Access Legal

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Corporate Counsel, US Market Access Legal
Duties: Counsel on drug price reporting and reimbursement issues, including advising on Medicaid, Medicare Part B, Department of Veterans Affairs, and 340B Program requirements, as well as state drug price reporting and transparency laws; Draft Centers for Medicare and Medicaid correspondence including letters and public comments on proposed rules and guidance; Develop price reporting compliance policies and reasonable assumption documents and advise on related internal training and audits; Lead internal legal resource on key industry market access policy issues, including pricing, reimbursement, authorized generics and payer innovations; Serve as the primary legal contact for assigned products and/or business units, acting as legal reviewer for advertising and promotional materials, as well as collaborating with other practice areas and functions relating to the assigned products and/or business units; Draft, negotiate, and review health care professional, vendor, licensing, consulting, speaker, advertising, sponsorship, and other agreements for commercial operations and medical affairs; Analyze product promotional initiatives, advisory board proposals, speaker programs, and medical education initiatives for FCPA, fraud and abuse, FDA, and other regulatory compliance; Advise on brand strategic planning and business operation plans; Review and advise on media relations materials including press releases, standby statements, Q&A documents, web sites and other company communications; Ensure that client operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations, antitrust, and FDA requirements; Work closely with internal teams to establish relationships and deliver consistent, practical legal guidance and support; Interact with and advise business leaders in the US concerning legal issues that have a direct effect on the success of the company. Operates with limited supervision, and therefore requires a high level of balanced judgment and an ability to independently discern and establish priorities. Agility and willingness to learn about various subject matters (both from a legal and business perspective) are highly valued. Ability to identify potential legal issues (focusing on fraud and abuse, antitrust, promotional, and regulatory matters) as well as proposed solutions to mitigate risk is required.

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