Compliance Manager en Vericel Corporation

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). 

Position Summary: 

Reporting to the Chief Compliance Officer, the Compliance Manager is responsible for the day-to-day leadership, operations, and program management of the Vericel Compliance program, which includes but is not limited to monitoring, training, development of policies and procedures, communications, third party due diligence, investigations, and risk assessment auditing and reporting.  This individual is the main point-of-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. The ideal candidate will have previous Artificial Intelligence experience to leverage expertise to build an efficient and scalable compliance program.

Schedule: 

This position is in-office from Monday – Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays. 

Position Scope: 

• Build an effective and scalable compliance program, leveraging experience and AI expertise.
• Serve as the legal representative in connection with the Company’s Medical, Legal and Regulatory (MLR) review process.  
• Utilize in-depth knowledge of the requirements of the Anti-Kickback Statute as they apply to commercial activities, the on-label promotion of the Company’s commercial products, as well as other laws, guidance and industry codes governing key biotechnology compliance areas.
• Serve as a trusted compliance advisor to the commercial and medical organizations.
• 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.
• Develop and deliver engaging compliance training and communications tailored to the needs of the business (including monitoring online and live training campaigns).
• Support the annual needs assessments for HCP engagements, ensuring compliance with all regulatory bodies. 
• Manage the Company’s compliance with Open Payments reporting obligations.
• Responsible for constructing procedures governing internal investigations as well as for the conduct of such investigations.
• Develop and execute monitoring plans to monitor in-person and transactional business activities.
• Support Vericel’s data privacy and protection efforts.
• Provide support on other matters requested by Legal Management, including with respect to litigation matters, and contracting responsibilities, as needed.
• Assist 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.

Qualifications:

• Bachelor’s degree and experience in Healthcare and Corporate Compliance is required.
• 5+ years of experience in corporate compliance in the medical device, pharmaceutical or biotech industry at companies with a marketed, commercial product.
• Successful AI application to design efficient compliance review processes.
• Knowledge of Health Care Compliance programs and policies, the AdvaMed code of conduct, state and federal open payments laws, Federal health care programs, and FDA requirements required. 
• Deep understanding of healthcare compliance laws, regulations, and industry codes of practice governing medical device and biopharmaceutical industry business practice, including but not limited to commercial, medical affairs, market access, and clinical development activities.
• Proficiency in Microsoft Office Suite, Veeva Vault, and contract management systems.
• Highly familiar with the current U.S. life science marketplace, including substantive knowledge of applicable U.S. laws relating to healthcare and pharmaceuticals, auditing, experience developing and implementing new policies, practices and related systems (i.e., CRM, Aggregate Spend).
• Exceptional written and verbal communication skills and interpersonal skills, with high degree of emotional intelligence.
• Proven ability to work cooperatively toward the most effective solutions in a dynamic, fast-paced, multidisciplinary environment including the ability to exercise sound business judgment, know when to seek the input of others, and work independently when efficiency is required.
• Commitment to integrity and ethical conduct; ability to handle confidential and proprietary information with discretion, and experience working in a high-growth public company environment.

Why Vericel? 

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

EEO Statement

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.