POSITION RESPONSIBILITIES

The Office of the General Counsel and the Division of Research Compliance in the Office of Human Research Affairs at Einstein are seeking an experienced attorney to oversee the Export Controls program and provide legal advice pertaining to research regulatory compliance. This role demands a high degree of discretion, flexibility, and excellent client service. The ideal candidate will excel in managing competing interests and executing projects within a dynamic and cutting-edge environment. This role will report to Senior Counsel at Einstein, Vice President and Counsel, Compliance at MMC and Director of Research Compliance at Einstein.

The Associate Counsel for Export Controls and Research Compliance provides guidance, direction and oversight to assure adherence to federal export control regulations and ensures that basic science and human subjects research activities of the Albert Einstein College of Medicine and Montefiore Medical Center (MMC) comply with relevant laws and institutional policies. The Associate Counsel at Einstein will collaborate with MMC counsel to advise researchers on compliance issues, including but not limited to:

• Serve as an institutional expert on export controls and research compliance (basic science, clinical and translational research, clinical trials, community and population health research)
• Provide legal counsel to College and MMC leadership, researchers, research administrators, and compliance committees on all aspects of research compliance.
• Disseminate information and develop procedures to facilitate compliance with export control regulations
• Disseminate information and develop educational resources for the research community to raise awareness of export control issues
• Serve as the official point of contact with export control regulatory agencies
• Conduct export control reviews and restricted party screenings and assist in the determination of export license requirements
• Coordinate with other organizational entities on export control issues
• Develop, maintain and implement policies, procedures, and communications related to research compliance and responsible conduct of research
• Assist internal auditors and other research-related offices with audits and site visits related to research compliance
• In collaboration with senior leadership, act as liaison to regulatory bodies, and assist in handling inspections, audits, and other regulatory interactions
• Compile data and generate reports for continuing quality improvement
• Identify and manage regulatory risks, and develop strategies to reduce the risk of fines, penalties, etc.
• Assist in training to ensure researchers and staff are informed of regulatory changes

QUALIFICATIONS

• Juris Doctorate (JD) degree from an accredited law school is required, a joint JD-MPH degree is preferred
• New York bar admission required
• Minimum 5+ years of professional work experience in a research compliance and export controls environment
• Comprehensive knowledge of federal regulations pertaining to basic science and human subjects research (e.g., FDA drug and device regulations, HIPAA, conflict of interest)
• Ability to analyze written material and apply what is learned to an analysis of current College or MMC policy and/or a review of a pending proposal
• Ability to develop compliance-related policies and implement these policies within the College and/or MMC community
• A track record of productive, collaborative relationships with a diverse community of researchers, executives and staff
• Ability to communicate effectively in oral, presentation, and written form with a range of audiences including administrators, faculty, federal and other state agencies, industry representatives, and other individuals interacting with the College/MMC research enterprise
• Experience working in a medical school/academic health center research environment is strongly preferred

Additional Information

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