Life Sciences Compliance Attorney
LabCorp is searching for a Life Sciences Attorney as a member of the LabCorp Corporate Legal Department. This Department is committed to a trusting and collaborative culture where we value growth and development. We engage proactively with our business colleagues in maintaining the company's commitment to a strong culture of compliance.
The successful candidate will:
- Possess working knowledge of regulatory, compliance, and other legal issues related to all phases of drug and device development, including: (1) FDA Regulations (and other international equivalents); (2) ICH-GxP requirements; (3) global medical device and in vitro diagnostic registration requirements; (4) transparency laws; and (5) human biological specimen regulations
- Provide day-to-day compliance and regulatory counseling
- Implement and oversee compliance policy and training updates
- Provide legal support in responding to government and client audits or investigations
- Participate in acquisition due diligence and integration of compliance program
- If you thrive in a fast-paced, hands-on, and team-oriented environment where you can have a big impact on the organization, we’d love to talk to you!
License/Certification/Education: A Juris Doctor (JD) degree from an ABA-accredited law school is required.
Education and Experience:
- JD from ABA accredited law school
- Minimum of 3-5 years of overall experience (law firm or in-house)
- Admission to a US State Bar
- Solid working knowledge of other laws, regulations, and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products
- Team player with excellent judgment and interpersonal/communication skills
- Ability to constructively counsel and influence clients in making the right decisions
- Capacity to simultaneously handle a variety of complex legal matters with minimal guidance
- Demonstrable experience taking ownership of issues and providing practical advice
- Ability to prioritize and undertake mission critical tasks in a fast-paced environment
- Contract negotiations, dispute resolution, policy and compliance matters within the business segment, novel business issues and contributes to the development and implementation of contracting policies and risk management strategies.
- Experience in the clinical research industry and working knowledge of regulatory, compliance, contracts and other legal issues affecting the health care industry, including: (1) fraud and abuse laws such as the Stark Law, Anti-Kickback Statute, False Claims Act and related OIG and DOJ regulations and guidance, as well as other state laws implicated in relationships between clinical laboratories and other health care entities; (2) Medicare and Medicaid reimbursement and billing rules applicable to clinical laboratory services; and (3) state and federal licensure laws applicable to clinical laboratories, such as CLIA is considered a plus.