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Compliance Counsel

Organogenesis

Any City, KSRemotePosted 40 days ago$110,000 - $145,000/year
Full TimeEntry LevelRegulatory AffairsBiotechnology
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Summary

The Compliance Counsel is primarily responsible for ensuring compliance within Organogenesis, and with laws, regulatory requirements, policies, and procedures. As a core member of the Compliance team, this individual is responsible for overseeing the US Transparency reporting processes, delivering clear and consistent compliance guidance, training employees and distributors/agents, reviewing contracts, and performing both live and transactional monitoring. This individual will also work proactively with other departments to assess and improve internal controls and business processes to enable the company to achieve its business goals and objectives in a compliant manner.

Job description

What You Will Achieve

The Compliance Counsel is primarily responsible for ensuring compliance within Organogenesis, and with laws, regulatory requirements, policies, and procedures. As a core member of the Compliance team, this individual is responsible for overseeing the US Transparency reporting processes, delivering clear and consistent compliance guidance, training employees and distributors/agents, reviewing contracts, and performing both live and transactional monitoring. This individual will also work proactively with other departments to assess and improve internal controls and business processes to enable the company to achieve its business goals and objectives in a compliant manner.

This position contributes to the departmental strategy and key strategic imperatives, optimizing the tactics for continuously evolving and improving the Corporate Compliance program. This individual will successfully partner with cross-functional stakeholders to execute on the organization’s goals, objectives, mission, vision and values compliantly and ethically. This position can be remote and reports to the Vice President of Healthcare Compliance.

How You Will Achieve It

  • Serve as an expert on compliance and US Transparency reporting for Organogenesis and oversee all Sunshine and state reporting processes
  • Develop and deliver training to education the organization to ensure understanding of employee responsibilities and ethics and compliance issues, related policies, and procedures.
  • Assist in developing the annual compliance work plan that reflects the organization's unique characteristics including an annual regulatory risk assessment.
  • Coordinate internal compliance review and monitoring activities, including periodic reviews of departments.
  • Provide support to VP of Healthcare Compliance on Corporate level initiatives, as needed.

What You Need to Achieve It

  • Juris Doctorate with active law license required
  • 1+ year of experience Healthcare Compliance required
  • Experience with US Transparency reporting strongly preferred
  • Ability to partner cross-functionally, counsel effectively, and inspire support for legal/compliance
  • Strong organizational skills and attention to fine details
  • An analytical thinker capable of autonomous decision making in matters of high risk and high complexity (with senior-level consultation, as appropriate)
  • Knowledge and understanding of compliance risk management practices and methodologies, including risk assessment, monitoring/surveillance, and testing activities
  • Willingness to work in a fast-paced environment and handle multiple, conflicting priorities while managing a substantial workload.

Requirements

  • Juris Doctorate with active law license required
  • 1+ year of experience Healthcare Compliance required
  • Experience with US Transparency reporting strongly preferred
  • Ability to partner cross-functionally, counsel effectively, and inspire support for legal/compliance
  • Strong organizational skills and attention to fine details
  • An analytical thinker capable of autonomous decision making in matters of high risk and high complexity
  • Knowledge and understanding of compliance risk management practices and methodologies, including risk assessment, monitoring/surveillance, and testing activities
  • Willingness to work in a fast-paced environment and handle multiple, conflicting priorities while managing a substantial workload

Benefits

  • 401(k) Matching
  • Medical, Dental & Vision
  • Flexible Spending Account
  • Health Savings Account
  • Short & Long Term Disability
  • Life Insurance
  • Paid Maternity & Parental Leave
  • Adoption Benefits
  • Education Assistance
  • Wellness Program
  • Employee Assistance Program
  • Paid Time Off
  • Free Parking
  • Discounts

Company overview

Organogenesis is a pioneering and commercial leader in regenerative medicine, founded in 1985 and headquartered in Canton, Massachusetts. As a leading biotechnology company, Organogenesis focuses on the development, manufacture, and commercialization of innovative solutions for the advanced wound care, surgical, and sports medicine markets. The company offers a comprehensive portfolio of regenerative products that address patient needs across the continuum of care, with flagship products including Apligraf and Dermagraft, which have collectively shipped over 1 million units for patient use. Organogenesis specializes in bioactive wound healing and soft tissue regeneration technologies, providing clinicians with evidence-based product solutions that integrate the benefits of regenerative medicine into everyday medical practice. With approximately 800 employees across multiple locations including Massachusetts, Alabama, California, Florida, and Switzerland, the company maintains a strong commitment to improving patient outcomes while lowering overall healthcare costs through its innovative healing solutions.

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