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Associate Corporate Counsel
Refer job# BWNU163676
 
Associate Corporate Counsel Duties: Drafting, negotiating and reviewing a wide range of agreements, including complex matters relating to procurement, licensing, clinical, and research activities; Advising the Company on matters associated with medical device product development, FDA approval and clearance, and post-market compliance, including creating and advising on a wide range of policy initiatives; Maintaining familiarity with laws that affect client areas in order to issue spot and provide basic counseling, including those relevant to sales and marketing of products to health care professionals and reimbursement by government programs, including, for example, fraud and abuse (Anti-Kickback Statute, False Claims Act), FDA regulation (Food, Drug & Cosmetic Act), privacy (HIPAA), and anti-corruption (Foreign Corrupt Practices Act); Partnering with the Medical Affairs and Clinical Affairs Department to support ongoing studies, strategies, operations and needs; Working closely with other members in the Legal Department and Ethics & Compliance Department to ensure consistency in approach across areas of the overall business and providing support for areas outside of your primary areas of responsibility as needed; Staying abreast of and advising on changes in laws/regulations, guidance documents, and industry trends affecting bioM rieux and its business, and assisting with development of policies and training as needed; Leading special projects as assigned and participating in cross-functional teams and committees while demonstrating leadership ability to colleagues and business partners; Helping select and/or directing the work of outside counsel, defining project objectives, managing projects, and monitoring outside counsel to ensure they operate within budget.

Qualifications: Law degree (JD) and admission (in good standing) to a state bar. 3-5 years of law firm and/or corporate legal experience. Experience advising all levels of clients on a wide variety of legal issues of interest to bioMerieux, including: commercial, legal regulatory, research and development, and clinical matters. Must be a self-starter with experience in the biologic, pharmaceutical, or medical device area (medical device preferred) as well as experience providing regulatory and general legal support in transactional matters. Ideally, the candidate will have experience representing drug, biologic, or medical device companies on drug development and commercialization matters and a working knowledge of these FDA-regulated industries. Familiarity with medical device premarket strategies, including: Investigation Device Exemption requirements, Premarket Notifications (510(k) clearances), Premarket Approval Applications (PMAs), De Novo Petitions, Pre-submissions, Product classification and reclassification. Exposure to and a general understanding of data privacy law, trends and concepts, including HIPAA and GDPR issues; Ability to travel domestically and internationally when travel resumes.
 
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