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Vericel® Corporation · 2 weeks ago

Legal Senior Compliance Manager

Burlington, MA

Full-time

Hybrid

Senior Level

$142K/yr - $181K/yr

5+ years exp

Vericel Corporation is a pioneer in advanced cell therapies for sports medicine and severe burn care. They are seeking a Legal Senior Compliance Manager responsible for leading the compliance program, ensuring adherence to regulatory requirements, and serving as a trusted advisor to the commercial and medical organizations.

BiotechnologyLife ScienceTherapeutics

Responsibilities

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

Qualification

Healthcare ComplianceCorporate ComplianceAI ApplicationMicrosoft Office SuiteVeeva VaultContract ManagementInterpersonal SkillsWritten CommunicationVerbal CommunicationEmotional Intelligence

Required

Bachelor's degree and experience in Healthcare and Corporate Compliance is required

5-8+ 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