Senior Compliance Manager

Role Summary

Senior Compliance Manager at Vericel Corporation, responsible for day-to-day leadership, operations, and program management of the Vericel Compliance program, including monitoring, training, policies and procedures, communications, third party due diligence, investigations, and risk assessment auditing and reporting. Acts as the main point-of-contact and compliance lead for the commercial and medical organizations within Vericel, serving as a primary contact for day-to-day contracting needs and other operational matters of a legal nature. Experience with Artificial Intelligence is preferred to build an efficient and scalable compliance program. This role is in-office Monday–Thursday in Burlington, MA with flexibility to work remotely on Fridays.

Responsibilities

• Build an effective and scalable compliance program, leveraging experience and AI expertise.
• Serve as the legal representative in connection with the Company‚Äôs Medical, Legal and Regulatory (MLR) review process.
• Utilize knowledge of the Anti-Kickback Statute and related laws, guidance, and industry codes governing biotechnology compliance areas for commercial activities and on-label promotion.
• Serve as a trusted compliance advisor to the commercial and medical organizations.
• Establish effective relationships within the Company, especially with senior management and operational leadership, fostering a culture of trust, integrity, transparency, and openness.
• Develop and deliver engaging compliance training and communications tailored to business needs (including monitoring online and live training campaigns).
• Support annual needs assessments for HCP engagements, ensuring regulatory compliance.
• Manage the Company‚Äôs Open Payments reporting obligations.
• Construct procedures governing internal investigations and conduct such investigations.
• Develop and execute monitoring plans for in-person and transactional activities.
• Support data privacy and protection efforts.
• Provide support on matters requested by Legal Management, including litigation matters and contracting responsibilities as needed.
• Assist in long-term strategic planning for the compliance program, staying abreast of best practices and evolving standards.

Qualifications

• Bachelor‚Äôs degree in Healthcare and Corporate Compliance is required.
• 5-8+ years of experience in corporate compliance in the medical device, pharmaceutical, or biotech industry with a marketed, commercial product.
• Experience applying AI to design efficient compliance review processes.
• Knowledge of Health Care Compliance programs, AdvaMed code of conduct, open payments laws, Federal health care programs, and FDA requirements.
• Deep understanding of healthcare compliance laws and industry codes governing medical device and biopharmaceutical business practices across commercial, medical affairs, market access, and clinical development activities.
• Proficiency in Microsoft Office Suite, Veeva Vault, and contract management systems.
• Strong knowledge of the U.S. life science marketplace and related laws, auditing, and policy development (CRM, Aggregate Spend).
• Excellent written and verbal communication skills and high emotional intelligence.
• Ability to work collaboratively in a dynamic, fast-paced environment and exercise sound business judgment; capable of independent work when needed.
• Commitment to integrity and ethical conduct; ability to handle confidential information with discretion; experience in a high-growth public company environment.

Skills

• Compliance program design and management
• Regulatory knowledge (FDA, AdvaMed, Open Payments)
• AI-enabled process improvement
• Training and communications
• Internal investigations and risk assessment
• Data privacy and protection
• Contract management and MLR processes
• Cross-functional collaboration and leadership

Education

• Bachelor‚Äôs degree required (Healthcare and Corporate Compliance focus preferred)

Additional Requirements

• Office location: Burlington, MA; in-office Monday‚ÄìThursday with Friday remote flexibility