A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.
The bioMérieux Legal Department is a dynamic team engaged in a wide variety of projects at many levels of the organization. The Associate Corporate Counsel position is an integral part of that environment where practicality, communication and collegiality are necessary components.
The Associate Corporate Counsel position will report to the VP and General Counsel- R&D, Medical Affairs and Business Development, and will be expected to provide a broad range of legal analysis, services, support and counsel to the business. As Associate Corporate Counsel, you will interpret laws, rulings and regulations to advise on legal matters including contracts and regulatory compliance matters, primarily in the pre-market arena. This position will act as a strategic legal partner to our senior managers (chiefly, Medical Affairs, Clinical Affairs, and R&D) in substantive legal areas on issues of FDA law, regulation and policy, government policy and enforcement, and in the compliance area, including:
- 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 bioMérieux 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.
Key Factors for Success
- Team Player & Contributor: Build strong relationships with business partners to tactfully influence and gain their support to drive desired outcomes. Bring with you an ability to independently and effectively manage a substantial workload in cooperation with and support of other attorneys on a variety of time-sensitive legal matters. Must demonstrate professionalism, confidence and ability to strike a balance between ambition and humility.
- Innovative: Holistic, big picture thinker, who anticipates changes in law, enforcement, and/or business objectives and adapts approach as necessary to manage risks effectively and mitigate issues before they arise.
- Solutions Oriented: Strategic legal thinking and capability of arriving at practical legal solutions. Demonstrate expertise and sound judgment, understand how assigned responsibilities support bioMerieux’s business objectives, and be able to provide practical, risk-balanced advice based upon a thorough understanding of the scope of an issue, taking full advantage of internal networks and external intelligence.
Required Qualifications and Skills
- Law degree (JD) and admission (in good standing) to a state bar.
- Three (3) to five (5) years of law firm and/or corporate legal experience.
- Demonstrated 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.
- The ideal candidate 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.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.