Senior Director, Compliance and Legal Operations
Senior Director, Compliance and Legal Operations
The Senior Director, Compliance and Legal Operations reports directly to the SVP, General Counsel and is responsible for the day-to-day leadership, operations, and program management of the Compliance program for Vericel. The position will provide oversight of compliance operations, which includes but not limited to monitoring, training, policies and procedures, communications, third party due diligence, investigations, risk assessment and reporting. The Senior Director, Compliance and Legal Operations also serves as the main contact and compliance lead for the commercial and medical organizations within Vericel, as well as a primary contact for all parts of the business with respect to day-to-day contracting needs and other operational matters of a legal nature.
- Lead Compliance team and continue to build an effective and scalable compliance program.
- Have a deep understanding of healthcare compliance laws, regulations, and industry codes of practice governing biopharmaceutical industry business practice including but not limited to commercial, medical affairs, market access, and clinical development activities.
- Keep apprised of legislative and regulatory developments on areas of compliance vulnerability and risk.
- Have in-depth knowledge of anti-kickback prohibitions as they apply to commercial activities, off-label promotion prohibitions, and other primary laws governing key biotechnology compliance areas.
- Establish effective working relationships and build credibility within the Company, especially at senior management and operational leadership levels, implementing a culture of trust, integrity, transparency, and openness.
- Assist the SVP, General Counsel in long-term strategic planning for the compliance program in response to effectiveness measures, continuous evolution activities and industry-leading best practices for effective compliance programs. Remain abreast of industry best practices and changing standards.
- Responsible for the compliance training program, including developing, launching and monitoring online and live training campaigns.
- Responsible for internal investigations procedure and conduct internal investigations.
- Develop and execute monitoring plan to monitor in-person and transactional business activities.
- Serve as a trusted compliance advisor to the commercial and medical organizations.
- Supervise and manage direct report to help run the compliance program.
- Support Vericel’s data privacy and protection efforts.
- Oversee implementation and maintenance of company’s contracts database.
- Serve as a primary legal contact for all parts of the business with respect to day-to-day contract needs.
- Provide support on all other matters requested by the General Counsel or other members of the Legal team, including with respect to litigation matters, as needed.
- Supervise external legal counsel on all of the above matters.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Leadership qualifications include, among other requirements:
- Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Bachelor’s degree, Advanced degree (e.g., JD/MA/MS/MBA), Healthcare Compliance Certification and further experience in Healthcare and Corporate Compliance, Finance, Auditing is required.
- 10+ years of experience in corporate compliance in the medical device, pharmaceutical or biotech industry at companies with a marketed, commercial product.
- Knowledge of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements required.
- Highly familiar with current US life science marketplace, substantive knowledge of applicable US laws relating to healthcare and pharmaceuticals, auditing, experience developing and implementing new policies, practices and related systems (i.e., CRM, Aggregate Spend)
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.