Vp Fisma Compliance Jobs (NOW HIRING)

Position Overview:

The Vice President, Compliance is a strategic leader responsible for designing, implementing, and continuously improving the company's Corporate Compliance Program to oversee promotional materials, field training, and HCP/patient programs. As an objective advisor, the Vice President, Compliance ensures the organization operates with integrity and in compliance with all applicable laws, regulations, and internal policies. Reporting to the Chief Legal Officer, the Vice President, Compliance partners with executive leadership, the legal and compliance function, the Audit Committee of the Board of Directors, and employees at all levels to foster a culture of ethical conduct and accountability.

Beam is transitioning to a commercial stage company, and this position plays a critical role in developing a culture of compliance.  Additionally, ex vivo cell therapy and in vivo gene therapy have unique commercial and operational needs that require a strategic leader to collaborate with commercial, medical, and manufacturing to build a commercial process that delivers for patients compliantly.

Key Responsibilities:

• Develop, execute, and evolve a comprehensive compliance strategy and program focusing on healthcare compliance and aligning with business objectives and legal requirements that meets the unique needs of cell and gene therapy.
• Provide proactive strategic advice to the business to help drive commercial success and ensure compliance with applicable laws and company policies, including federal and state anti-kickback and false claims laws; U.S. and other country anticorruption laws; the federal Food, Drug and Cosmetic Act; and federal and state transparency laws.
• Serve as Chair of the Beam Compliance Committee and as Data Privacy Officer.
• Provide regular updates on the Compliance Program to executive leadership and the Audit Committee of the Board of Directors.
• Review business strategy plans and business development opportunities for compliance risks and advise the business on how to mitigate those risks.
• Develop and maintain trusting relationships with key client groups, such as commercial and clinical, and serve as a trusted and strategic advisor and resource.
• Act as a compliance champion to reinforce a culture of integrity and raise awareness of compliance as a collective responsibility of all company personnel.
• Champion open communication by ensuring employees feel empowered to raise concerns without fear of retaliation.
• Oversee ongoing education initiatives to enhance understanding of the Code of Business Conduct & Ethics, Beam policies and procedures, and emerging compliance risks, and seeking opportunities for continuous learning across the organization.
• Continuously assess the effectiveness of the compliance program through data-driven audits, risk assessments, and performance metrics. Identify gaps and support the design and tracking of corrective actions to strengthen compliance controls.
• Manage and conduct compliance investigations, working with internal business partners to identify appropriate corrective and preventive actions.
• Stay ahead of regulatory and industry code changes and industry and enforcement trends impacting compliance areas and proactively advise leadership on potential impacts and necessary adaptations.
• Serve as a trusted advisor to the Board of Directors, Chief Legal Officer, executive leadership team, and other functions, providing actionable guidance on compliance matters and risk mitigation.
• Engage with outside counsel, regulatory agencies, and industry groups to understand and benchmark the best practices and ensure the compliance regime meets or exceeds industry standards.

Qualifications:

• Bachelor's degree required, Juris Doctorate or advanced degree a plus.
• Cell and gene therapy experience a plus.
• Relevant experience (typically 7 years or more, or equivalent combination of education, training, and experience) with a deep understanding of compliance issues confronting the pharmaceutical/biotech industry.
• Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the U.S. Sentencing Guidelines.
• Demonstrated effectiveness operating in complex organizational and regulatory environments and experience with Code implementation (PhRMA, EFPIA, IFPMA)
• Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical industry including sales and marketing, OIG and other industry guidance documents, regulations on the promotion of marketed products, clinical trial regulations, patient privacy and issues arising under the False Claims Act, anti-bribery/anti-corruption laws, and other related laws.
• Business focused and solution oriented.
• Excellent written, oral and presentation skills.
• Proven ability to work with all levels of management.
• Strong problem-solving and analytical skills.
• Self-motivated and able to perform role independently, with a minimum level of supervision.
• Demonstrated ability to partner effectively with others in addressing complex issues.
• Strong influencing skills and sound business judgment.
• Ability to appropriately prioritize issues.
• Outstanding attention to detail.