Associate Director, Compliance

Vericel Corporation • Burlington, MA

1d • $200,000 - $230,000 • Hybrid

About The Position

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).

Summary:

Reporting to the Chief Compliance Officer, the Associate Director of Compliance 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 monitoring, training, drafting policies and procedures, drafting and review of communications, conducting third party due diligence, investigations, risk assessments and managing compliance reporting obligations.  The Associate Director of Compliance will have responsibilities across the legal organization, serving as one of the main points-of-contact and compliance leads for the commercial, clinical and medical organizations within Vericel.

Schedule: This is a hybrid position based in our Burlington, MA office.

Requirements

• Bachelor’s degree or above and experience in Healthcare Compliance, including experience in the medical device and/or biologic pharmaceutical industries.
• 7+ years of experience in corporate compliance in the medical device, pharmaceutical or biotech industry at companies with a marketed, commercial product.
• Subject-matter experience and knowledge of healthcare compliance programs and policies, anti-kickback rules and regulations, Open Payments and Sunshine Act, the AdvaMed and/or PhRMA Code of Ethics, and FDA advertising and promotion rules and requirements is preferred.
• 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, Concur, Aggregate Spend).

Responsibilities

• Continue to build an effective and scalable compliance program.
• Have a deep understanding of healthcare compliance laws, regulations, and industry codes of practice governing medical device, pharmaceutical and/or biologics industry business practices, including but not limited to commercial, medical affairs, market access, and clinical development activities.
• Keep apprised of the various laws, regulations and industry guidance's the company’s compliance program, including OIG and DOJ guidelines, the AdvaMed code, state and federal privacy laws and state marketing compliance laws.
• Have in-depth knowledge of anti-kickback prohibitions as they apply to commercial activities, FDA rules regarding off-label promotion prohibitions, and other laws and regulations that govern 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.
• Serve as the legal representative in connection with the Company’s Medical, Legal and Regulatory (MLR) review process for promotional materials and communications.
• Coordinate and manage transparency reporting in compliance with federal and state open payments laws.
• Assist in long-term strategic planning for the compliance program including maintaining industry-leading best practices for effective compliance programs. Remain abreast of industry practices and changing standards.
• Assist with the compliance training program, including developing, launching and monitoring online and live training campaigns for Sales, Marketing, Medical Affairs and other relevant departments.
• Assist with maintaining internal investigation procedures as well as conducting investigations into suspected violations of the Company’s Code of Conduct and compliance policies.
• Participate in audit activities including monitoring in-person and transactional business activities including periodic observation of sales personnel and speaker programs, advisory boards, and sponsorship activities.
• Serve as a trusted compliance advisor tothe commercialand medical organizations.
• Provide support on all other matters requested byLegal Management, including litigation matters, and contracting responsibilities, as needed.
• Supervise external legal counsel and vendor relationships for all of the above matters.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level