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Years of Experience
ProfileSenior Corporate Counsel, Healthcare Law Group The candidate will work as part of the Healthcare Law Group within firm's Legal department. Will provide legal advice and support across the lifecycle of firm's products, including pipeline, commercial and medical affairs functions. Supported teams include brand sales and marketing teams, commercial strategic and operational functions, and medical affairs teams that have human medicines in all phases of development, and manufacturing. Providing advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products. Serving as a standing or ad hoc member of business or leadership teams and providing legal counsel and expertise into business decisions. Advising on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies. Reviewing business materials (including brand plans, promotions, medical plans, training documents) requiring legal input and advises internal clients, partners and stakeholders on compliant strategies, plans and tactics. Advising clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use. Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities. Developing and implementing training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance. Educating clients and partners about current enforcement trends.
Qualification and Experience
The candidate should have JD degree with Bar admission from a top tier law school, and between 5-7 years of relevant legal experience at a law firm with a nationally-recognized FDA / Life Sciences practice or in a pharmaceutical or biotechnology companyâ€™s law department, with a focus on counseling pharmaceutical and/or clinical clients on U.S. and international rules related to the promotion, clinical development, and manufacture of human medicines. Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the pharmaceutical and biotech industries is preferred, along with excellent oral and written communications skills.
Job ID: 3593889512
1 DNA Way
South San Francisco, CA 94080-4990