Description Position Summary & Responsibilities:
This role can be based in either Durham, NC or Salt Lake City, UT. The successful candidate will provide advice and counsel on a wide variety of issues including commercial, regulatory, compliance, and litigation. The candidate must demonstrate an ability to interact with all levels of the organization as a key individual contributor.
- Address a wide range of transactional matters, including drafting and negotiation of contractual relationships, with a significant focus on supporting sales, marketing, operations, and clinical research relationships with customers, suppliers, service providers, collaborators, and consultants.
- Review marketing, promotional, and scientific activities and materials for compliance with company policies and applicable laws and regulations.
- Provide guidance and training to assure compliance with applicable laws and regulations, including analysis of relationships with healthcare professionals both in the US and abroad, including but not limited to the US anti-kickback law, the FCPA and other anti-corruption laws, and helping to ensure that bioMerieux's compliance program is robust and effective at managing and minimizing risk.
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics' and bioMerieux's Quality Systems.
- Ability to work with all functional areas and levels of the organization to address a wide variety of issues.
- Partner closely with other bioMerieux legal department colleagues on various initiatives.
- Provide analysis and counsel on various other relevant legal issues as they arise, including but not limited to pricing and reimbursement of medical devices, regulatory matters, data privacy, and competition law.
- Keep track of developments in medical device regulation and enforcement and other areas of responsibility, and apply that knowledge to anticipate and address emerging risks to the company.
- Actively engage/manage external legal counsel to ensure appropriate service and quality levels and contain costs.
- Design and deliver training programs for business colleagues on a variety of subjects.
- Manage and monitor the Company's contract terms.
- Employ and exercise judgment to analyze issues and make recommendations with minimal or no supervision.
- Performs other duties as assigned.
Education, Skills, & Experience:
- J.D. and bar admission required with 3+ years of law firm or in-house legal experience in commercial transactions, litigation, or health care related fields.
- Healthcare experience is a plus. Prior experience in medical device, health care, life sciences, or clinical diagnostics is a significant plus.
- Previous experience supporting Sales or Commercial Operations is a plus but not required
- Excellent communication skills to interact with and influence colleagues.
- Creativity, flexibility, initiative, and enthusiasm to achieve results and overcome obstacles; pragmatic business sense able to recognize commercial implications of legal advice and provide practical alternatives.
- Collaborative team player able to build positive relationships with colleagues and lead and direct cross-functional teams.
- Ability to independently and effectively manage a substantial workload in a fast-paced environment and cooperate with and support of other company attorneys and outside counsel.
- Must possess superior decision-making and interpersonal skills, excellent drafting and negotiation skills, attention to detail, and a sense of discretion.
- Genuine desire to work in a global business environment that involves broad cultural variety, with a high level of enthusiasm for diversity of work.
- Willingness to undertake some travel, including international travel, in support of responsibilities.
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bioMerieux Inc.
Dec 10, 2024