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Senior Counsel The candidate will provide broad-based advice to support the healthcare law function at Dermira. Will provide regulatory, transactional and general legal support to the commercial, development, clinical and medical affairs organizations. Interact with key company leaders, government agencies, law firms, trade organizations and other external agencies. Serve as lead counsel for one or more pharmaceutical brands, including participation in cross-functional committees charged with setting commercial strategies as well as reviewing advertising, scientific and other materials (e.g. promotional review committee, medical review committee, etc.). Understand the strategic and tactical objectives of the business and developing creative and thoughtful solutions, considering the current legal and regulatory landscape, Dermira policies and procedures and the current and future needs of the organization. Review and provide oversight on a variety of commercial, clinical, and operational contracts. Advise on supply chain, including manufacture, distribution, reimbursement and price reporting. Liaise with an independent compliance function to ensure risk based advice is consistent with company policies and training messages, and can be implemented in accordance with company procedures. JD degree from a nationally recognized law school with strong academic credentials are needed. Should have 4-10 years of legal experience with a healthcare-related law firm, regulatory agency, or a life sciences or pharmaceutical company counseling on legal issues relating to advertising and promotion, scientific exchange, patient support programs, interactions with health care professionals, reimbursement, and privacy. Should possess knowledge of laws and regulations relating to the discovery, development, manufacture, distribution and commercialization of pharmaceutical products, including FDA advertising and promotional regulations, labeling, GXP, pharmacovigilance, products liability, the Anti-Kickback Statue, the False Claims Act, HIPAA, OIG Guidance, the PhRMA Code, sunshine reporting obligations, etc. Provide legal support to Compliance relating to policies, trainings, corrective actions and applicable federal/state transparency reporting. Excellent verbal and written communication skills, including the ability to communicate substantive legal advice and actionable risk assessment at appropriate levels within the organization to help the company meet its business objectives.
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