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We are seeking an collegial, detail-oriented and motivated attorney to lead the healthcare law function at Achaogen. This person will report to the General Counsel and manage development law, FDA regulatory legal support and be responsible for commercial compliance activities.
Must have prior experience in-house with biotechnology or pharmaceutical company in a relevant area
Manage the operation of commercial compliance, working with the Commercial and Medical Affairs groups.
Analyze and advise on legal obligations and rights to support achievement of Commercial and Development objectives.
Work with third-party collaborators on Commercial issues.
Provide advice with respect to rules and regulations governing the development and commercial launch and sale of products, including reviewing and approving publications and promotional materials.
Participate on review committees with respect to medical publications, MSL materials, grants, sponsorships, speakers programs, consultant and advisory board meetings, grand rounds, and similar activities involving communications with healthcare entities.
Provide legal protection and risk management advice to management.
Lead the designing of policies, SOPs and training to comply with all applicable rules and regulations, including those of the FDA, OIG and CMS, and all applicable anti-kickback, privacy, fraud and abuse, anti-bribery and product liability laws.
Assist in compliance monitoring, audits and investigations.
Achaogen is a biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterials to treat multi-drug resistant gram-negative infections. We are anchored by our key values of integrity, accountability, transparency, scientific rigor and drive. We pride ourselves in creating a work community that is scientifically driven, supportive, an...d collaborative. We encourage the diversity of thought that leads to great innovation and are looking to add to our dynamic team with people who are driven to transform the lives of patients.