Associate General Counsel Compliance

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Associate General Counsel, Compliance
Responsibilities: 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. Develop and execute a comprehensive compliance training program for employees and designated third parties on applicable compliance policies, laws and regulations, including any new developments or updates that may impact the Company’s compliance program. Serve as the lead legal resource for the Company’s Clinical, Medical, Patient Advocacy and Engagement and Regulatory teams. Provide compliance guidance and oversight in the review of scientific, clinical, medical, corporate, educational, marketing, promotional, advertising and training materials and programs to ensure compliance with applicable laws, rules and regulations, including advising on advisory boards, scientific and medical conference materials and publications, grants, sponsorships, donations, and other initiatives involving interactions with healthcare professionals, patients, and patient advocacy organizations. 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. Institute and maintain effective compliance communications within the Company by promoting awareness and retention of the Code of Business Conduct, the use of the Company’s compliance hotline, as well as other means for employees to report compliance-related concerns or engage with senior leadership. Monitor and advise on new and proposed legal and regulatory developments, market trends and best practices in the areas of healthcare compliance, FDA, privacy, and emerging regulatory risk areas to ensure the Company’s continued compliance. 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. Regularly educate and inform the Company’s senior management on matters related to the Company’s compliance program, including providing periodic reports for members of senior management, the board and other stakeholders regarding the Company’s compliance efforts, risks and effectiveness. Ensure that the audit committee is immediately notified of concerns or reports of compliance violations. Obtain and maintain a strong working knowledge of the Company’s business, scientific capabilities, and key strategic business objectives.

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