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Vice President, Deputy General Counsel, Compliance
Refer job# CIXH161093
 
Vice President, Deputy 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, 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 pre-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 Medical, Clinical Development, Patient Advocacy and Engagement, Commercial and Regulatory teams. Provide compliance guidance and oversight in the review of scientific, clinical, medical, corporate, educational, 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 and other agreements, informed consent forms and 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 enterprise risk and collaborate with functional leaders to strengthen the Company's practices as appropriate to mitigate risk. Regularly educate and inform employees 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. Obtain and maintain a strong working knowledge of the Company's business, scientific capabilities, and key strategic business objectives.

Qualifications: JD degree from an accredited law school. Current member in good standing of a U.S. state bar (Massachusetts preferred). 5-10+ years as a practicing attorney in the field of healthcare compliance advising both clinical-stage and commercial biotechnology or pharmaceutical companies; prior in-house and law firm experience preferred. Extensive expertise with compliance matters relating to the development, approval and commercialization of biotechnology or pharmaceutical products, privacy, and FDA issues, with an understanding of the OIG Guidance, applicable laws and regulations relating to the development, advertising, promotion, sales and marketing of pharmaceutical products and the current federal and state enforcement landscape. Experience developing and implementing effective compliance policies and programs. Comprehensive knowledge of U.S. healthcare fraud and abuse laws, FDA, OIG, FCPA, and CMS regulations, rules and guidances, pharmaceutical marketing, price reporting, privacy, federal and state disclosure requirements. Experience in drafting and negotiating a range of agreements relating to research, clinical, and commercial activities relevant to a biotechnology or pharmaceutical company. Strong written and oral communications skills required to work both internally and externally. Ability to meet deadlines while managing a substantial workload in a fast-paced environment. Ability to recognize risk and develop workable strategies to mitigate such risk. Ability to engender confidence when advising clients at all levels. Ability to work with little oversight. Ability to work with the highest level of integrity is essential. Excellent business judgment and strategic thinking. Flexibility and willingness to work on a broad variety of legal matters.
 
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