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Compliance Attorney
Refer job# LBNU162442
Compliance Attorney The candidate must have: License/Certification/Education: A JD degree from an ABA-accredited law school is required. Admission to a US State Bar. 3-5 years of overall experience (law firm or in-house). 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. Experience in the clinical research industry and working knowledge of regulatory, compliance, 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. 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.

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