Regulatory Compliance Counsel
The candidate will oversee the Corporate Compliance Program and review and evaluate compliance issues/concerns within the organization. Will ensure that all members of the organization are adhering to and are in compliance with the regulatory policy, procedure, and standards as described by the business and required by applicable laws, regulations, policies, and guidance. Manage day-to-day operation of the program. Develop, initiate, maintain, and revise policies and procedures for the general operation of the Compliance Program and its related activities to prevent illegal, unethical, or improper conduct. Develop and periodically review and update Standards of Conduct to ensure continuing currency and relevance in providing guidance to management and employees. Collaborate with other departments to direct compliance issues to appropriate existing channels for investigation and resolution. Respond to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures. Develop and oversee a system for uniform handling of such violations. Act as an independent review and evaluation body to ensure that compliance issues/concerns within the organization are being appropriately evaluated, investigated and resolved. Monitor, and as necessary, coordinate compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends. Identify potential areas of compliance vulnerability and risk. Develop/implement corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future. Provide reports on a regular basis, and as directed or requested, to keep senior management informed of the operation and progress of compliance efforts. Ensure proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or required.
The candidate should preferably have J.D. or other Master's level degree or equivalent combination of education, training and experience. License to practice law is strongly preferred. Should preferably be Certified in Healthcare Compliance (CCH) or equivalent, Certified in Healthcare Research Compliance (CHRC) or equivalent, or Certified IRB Professional (CIP). Must have 6+ years of experience in a health care in-house legal or compliance department. Should also have 5+ years of experience in a management role within a healthcare or clinical research organization with 3+ years of experience overseeing Corrective And Preventive Action plans, working with Change Control boards in the implementation of change to policy and procedure, and directly working with regulatory agencies. Should have demonstrated working knowledge of regulatory affairs related to clinical research and compliance. Must build and maintain a working knowledge of: applicable health care laws, regulations, policies, and guidance including 21 CFR Part 11 Compliance and OFCCP and EEO compliance; legal and compliance terminology, concepts, and processes; operational, financial, compliance, quality assurance, Information, Technology, and human resource procedures and laws, regulations, policies, and guidance; and research and corporate compliance issues and related laws, regulations, policies, and guidance.
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