Life Science Attorney

$90,000 - $130,000 yearly
  • Labcorp
  • Burlington, NC, USA
  • Sep 27, 2021
Full time Biotech Health Care Pharmaceutical

Job Description

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!

Education/Qualifications

Requirements

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.