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Years of Experience
ProfileAssociate General Counsel
Qualification and Experience
Qualifications: JD Degree from an ABA-accredited law school. License to practice as an attorney in at least one US jurisdiction. 10+ years of relevant experience. Experience working in the legal department of a commercial-stage pharma/biotech company. Experience providing legal counsel on new product commercialization activities. Significant knowledge and expertise of either FDA or health care compliance considerations relevant to the biopharmaceutical industry. In-house experience providing risk assessments and legal counsel regarding financial interactions with health care professionals, scientific or product communications with health care professionals or payors, and healthcare compliance. Must be able to manage conflicting priorities in fast-paced environment, and work independently on a wide range of issues and projects, while delivering high-quality work under a tight timeline. Familiarity with corporate compliance programs; comprehensive understanding of legal terms, and excellent negotiation skills . Proven ability to develop and implement legal strategies that support business and financial objectives. Strong attention to detail. Excellent communication skills (verbal and written). Ability to apply legal concepts and practical judgment to dynamic business needs. Strong interpersonal skills with ability to effectively communicate with all levels of personnel. High energy level and high degree of self-motivation, with a sense of urgency to achieve stated business goals. Demonstrate ability to think creatively and devise solutions to challenging problems. Ability to mentor legal staff in areas of expertise. Sound judgment and commitment to ethical conduct. Strong knowledge and understanding of all healthcare laws, guidance documents or opinions, and industry codes relating to the discovery, development and commercialization of biopharmaceutical products, including but not limited to FDCA, FDA guidance Documents, Fraud and Abuse laws, Anti-kickback Statute, federal and state transparency laws, and OIG Advisory Opinions, etc. Preferred: A combination of both in-house experience in a biotechnology company and law firm practice. Degree in a scientific discipline.