Corporate Compliance Officer

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Corporate Compliance Officer
Responsibilities: Responsible for continued development and maintenance of the corporate compliance program for medical and non-medical products and services. Provide advice and counsel on a day-to-day basis to ensure the Company is in compliance with applicable FDA regulations, advertising and promotion, anti-kickback, fraud and abuse, privacy, and anti-bribery laws and regulations, interactions with patients, healthcare professionals and other external parties, state law compliance and reporting requirements, and other aspects of federal and state laws and regulations governing pre-clinical research, clinical development, manufacturing and commercialization of the Company’s gene therapies. Design, implement, monitor and enforce a Company-wide compliance program and associated policies and procedures in order to promote and reinforce a culture of ethical business conduct, principles and practices, in conformity with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance) and industry best practices. Serve as the lead legal resource for the Company’s Clinical, Medical, Patient Advocacy and Engagement and Regulatory teams. Draft, review and negotiate contracts including clinical trial agreements, commercial contracts, third party vendor agreements, consulting agreements, informed consents and other agreements, including advising on fair market value (FMV) metrics. Identify potential areas of compliance vulnerability and risk for the Company and collaborate with functional leaders to strengthen the Company's practices as appropriate to mitigate risk. Review/or coordinate the review of independent contractor arrangements to ensure that all applicable laws and regulations have been followed.

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