Vericel® Corporation

Compliance Manager

Vericel® Corporation

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Job Level

Mid-LevelSenior

Tech Stack

Vault

About the role

  • Reporting to the Chief Compliance Officer, responsible for day-to-day leadership, operations, and program management of the Vericel Compliance program.
  • Serve as the main point-of-contact and compliance lead for the commercial and medical organizations within Vericel.
  • 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 Anti-Kickback Statute and laws governing biotechnology compliance areas.
  • Establish effective working relationships and build credibility within the Company, especially at senior management.
  • Develop and deliver engaging compliance training and communications, including monitoring online and live training campaigns.
  • Support annual needs assessments for HCP engagements and manage Open Payments reporting obligations.
  • Construct procedures governing internal investigations and conduct such investigations.
  • Develop and execute monitoring plans for in-person and transactional business activities.
  • Support data privacy and protection efforts and provide support on Legal Management matters including litigation and contracting as needed.

Requirements

  • 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.
  • Deep understanding of healthcare compliance laws, regulations, and industry codes of practice governing medical device and biopharmaceutical industry business practice.
  • Proficiency in Microsoft Office Suite, Veeva Vault, and contract management systems.
  • 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.
  • Commitment to integrity and ethical conduct; ability to handle confidential and proprietary information with discretion.
  • Experience working in a high-growth public company environment.