Senior Attorney
The candidate will provide advertising and promotion, regulatory, contracting, and general legal support to the company, specifically to the Commercial and Medical Affairs departments. Will serve as the legal business partner in support of the Commercial and Medical Affairs departments with oversight and guidance by the General Counsel. Report to the General Counsel and will interact daily with the Commercial, Medical Affairs and Regulatory Affairs departments, and may also interact with government agencies, law firms, trade organizations and other external agencies. Manage the company's healthcare compliance program, including the update, maintenance and consistent implementation of policies, and coordinate and/or provide training as needed. Participate in multidisciplinary committee reviews of advertising and promotion, grants and other payments to healthcare professionals, scientific and other materials as well as attend project team meetings as needed to provide legal feedback on commercial strategy. Coordinate with other members of the Legal department to provide comprehensive and consolidated legal responses to review committees and questions from internal departments and teams. Draft, review and negotiate product-related commercial agreements such as service agreements, consulting agreements and other agreements. Address potential healthcare/FDA compliance issues to prevent or minimize legal risk to the company. Work with internal stakeholders to achieve business goals within a compliance framework. Keep informed of new US healthcare laws, regulations, and industry trends affecting the company.
The candidate should have a J.D. degree with 8+ years of relevant industry and/or law firm experience. Graduation from an accredited law school is required. Admission to a State Bar and active license to practice law is needed. Experience at a pharmaceutical or biotechnology company supporting marketed products preferred. Specific expertise in FDA advertising and promotion regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required.
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