The bioMérieux Legal Department is a dynamic team engaged in a wide variety of projects at many levels of the organization. The Sr Corporate Counsel, Healthcare and Policy position is an integral part of that environment where practicality, communication and collegiality are necessary components.
The Sr Corporate Counsel, Healthcare and Policy position will report to the VP and General Counsel, North America, and will be expected to provide a broad range of legal analysis, services, support, and counsel. As Sr Corporate Counsel, you will interpret laws, rulings, and regulations to advise on legal matters, including contracts and regulatory compliance matters, primarily in the healthcare regulatory, compliance, and policy arena. In partnership with your legal teammates, this position will act as a strategic partner to our senior managers (chiefly, US Medical Affairs, Marketing, Market Access and Government Affairs) in substantive legal areas on issues of FDA law, regulation and policy, government policy and enforcement, and in the compliance area, including:
- Advising on promotional activity related to marketing and sales pieces including review marketing and promotional materials for compliance with company policies, industry standards, applicable laws and regulations. Providing guidance regarding same;
- Advising the Company on matters associated with medical device product development, FDA approval and clearance, product launch, and post-market compliance, including creating and advising on a wide range of policy initiatives
- Maintaining familiarity with laws that affect client areas 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, Marketing, Market Access, and Government Affairs teams 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;
- Provide legal advice to the Ethics & Compliance function as needed;
- Support the Quality team to ensure compliant quality management systems;
- Staying abreast of and advising on changes in laws/regulations, guidance documents, and industry trends affecting bioMérieux and its business, and assisting with the 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 a 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 other attorneys on a wide range 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 the 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 bioMérieux’s business objectives, and 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.
- Eight (8) - fifteen (15) 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) and 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;
- Prior in-house experience in the medical device industry is a plus.
- Ability to travel domestically and internationally.