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Corporate Counsel Commercial Brands
Refer job# QBCE159864
 
Corporate Counsel - Commercial Brands The candidate will provide advice, guidance, and counsel to internal brand teams regarding advertising and promotion, sales and marketing initiatives, compliance rules and regulations, FDA and OIG guidance documents, and industry codes (e.g., PhRMA) as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations. Provide advice, guidance, and counsel to commercial, medical, and corporate teams on management and marketing strategies, programs, policies, practices, and initiatives with respect to compliance with relevant healthcare laws, guidance documents or opinions, and industry codes (FDCA, FDA guidance documents, Fraud and Abuse laws, Anti-kickback Statute, federal and state transparency laws, OIG Advisory Opinions, FCPA, etc.). Provide legal advice and lead the negotiation and drafting of contracts for the Market Access team. Provide legal analysis and risk-based recommendations regarding the compliance rules and regulations (e.g., advertising & promotion, fraud & abuse, anti-kickback, privacy, and false claims act statutes) implicated by proposed or existing business strategies. Review and analyze advertising and promotional initiatives, pipeline products/clinical trial recruitment materials, grants/donations and sponsorships, and related research on FDA/OIG enforcement activities. Work with internal functional areas to identify, analyze, and mitigate risks, and also support the development, implementation, and maintenance of healthcare compliance & ethics programs, including counseling and training on compliance policies and healthcare compliance regulations. Provide analysis, guidance, and support to the Medical Affairs department members, including Medical Directors, Medical Information, and Medical Science Liaisons. Provide analysis, guidance, and support on patient advocacy matters. Assist with periodic compliance risk assessments and resulting work plans. Assist in the creation of training plans and training modules in connection with compliance policies, including new hire orientation, anti-bribery and anti-corruption program, privacy, and promotional regulations. Present training to business units as needed. 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. Assist with investigations of alleged violations of compliance policies, laws, regulations, or procedures. Develop and implement corrective action plans where compliance violations have been established. Serve as a legal representative on cross-functional Promotional. Review Committees to provide legal feedback and direction on advertising, promotional and educational materials submitted for review.

The candidate should have JD and an active license to practice law. Must have 5+ years of practicing law, with 3+ years of relevant experience in the biotech/pharma or healthcare industry. In-house experience is strongly preferred. Additional experience at a regulatory agency or major law firm is a plus. Must have significant experience supporting branded pharmaceutical products as cross-functional legal lead, including participation in promotional and medical review processes. Must have strong knowledge of the legal/compliance framework affecting the pharmaceutical/biotechnology industry, including sales and marketing, fraud and abuse issues, OIG and other industry guidance documents, and issues arising under the Anti-Kickback Statute and the False Claims Act. Experience drafting and negotiating pharmaceutical commercial contracts (including payor and distribution agreements) is desired. Must have the ability to work with a high degree of autonomy and collaborate cross-functionally in a constantly changing, fast-paced environment with multiple competing deadlines. Accountability, sound judgment, and the ability to take ownership of an issue and recognize the business impact of legal advice is required. The ability to think creatively, devise practical solutions to challenging problems, and effectively drive legal and business issues to closure are essential.
 
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