Ethics & Compliance Specialist/Senior Specialist

About the role

Shape ethical business practices on a global scale. Join Kedrion as a key driver of healthcare compliance and integrity.

Responsibilities

• Implement and manage Global Ethics & Compliance initiatives across assigned business lines, functions, and markets, including the U.S.
• Complete, maintain, and update periodic compliance risk assessments to identify and mitigate emerging risks.
• Monitor changes in applicable laws, regulations, industry guidance, and best practices that impact the Ethics & Compliance System.
• Draft, implement, and maintain compliance-related policies and procedures, including version control, change tracking, and effective rollouts.
• Develop and deliver compliance training programs and awareness communications for employees and stakeholders.
• Design and integrate compliance controls into company processes to ensure effective risk management.
• Present Ethics & Compliance topics and initiatives to internal and external stakeholders as required.
• Conduct and facilitate auditing and monitoring activities to assess program effectiveness.
• Manage and support U.S. and global transparency reporting.
• Manage and support third-party due diligence activities, including review and approval processes.
• Contribute to the Global Speak Up Program and support Ethics & Compliance–related investigations.
• Prepare and deliver periodic reports to company management on monitoring outcomes and compliance initiatives.
• Support the Global Compliance Officer and Global Ethics Compliance team in identifying and implementing improvements to the E&C System, with particular focus on the Commercial organization.
• Participate in performance improvement projects, including the definition and measurement of compliance metrics.
• Partner cross-functionally with Legal, Finance, IT, HR, Internal Audit, Quality, and Commercial teams to ensure the Ethics & Compliance System is well designed, effectively implemented, and aligned to business needs.
• Provide independent compliance advice to help manage and mitigate organizational risk.

Requirements

Qualified candidates must live in either the Fort Lee, NJ area or Raleigh, NC area.

Qualifications

• Bachelor’s degree required.
• 3–5 years of relevant healthcare compliance experience within pharmaceutical, biotechnology, or medical device organizations.
• Solid understanding of the elements of an effective compliance program, including guidance issued by the U.S. Department of Justice and Office of Inspector General.
• Experience with healthcare compliance regulations and interactions with healthcare stakeholders such as healthcare professionals, organizations, patient organizations, and payors.
• Knowledge of anti-bribery and anti-corruption legislation, including the Foreign Corrupt Practices Act and similar global regulations.
• Experience compiling and working with compliance data and analytics.
• Intermediate to advanced proficiency with Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint.
• Fluency in English; additional language skills are beneficial.
• Ability and willingness to travel up to 25% as needed.
• Compliance certification (e.g., CCEP, CCEP-I) preferred.

Benefits

This position does not offer visa sponsorship now or in the future.