Alkermes

Healthcare Compliance Associate


PayCompetitive
LocationWaltham/Massachusetts
Employment typeFull-Time

This job is now closed

  • Job Description

      Req#: 13441

      Healthcare Compliance Associate

      The Healthcare Compliance Associate will report to the Director of Healthcare Compliance on the Compliance Monitoring and Auditing Plan. This position will require extensive domestic travel and will play an important role in fostering a culture of compliance.

      Responsibilities:

      • Conduct in-person monitoring of Commercial and Medical Affairs activities, perform internal audits, and review documentation to help ensure compliance with applicable laws, regulations, and company healthcare policies and procedures.
      • Assist with corrective action plans for any issues identified during monitoring, audits, or documentation reviews.
      • Maintain records of audits and monitoring activities.
      • Build strong relationships with the Commercial and Medical Affairs organizations to foster open communication.
      • Provide compliance guidance on daily employee activities, including responding to policy-related questions from the sales organization during monitoring efforts.
      • Analyze audit findings and compliance data to identify trends, patterns, and areas of concern. Assist in generating reports for leadership based on these analyses.

      Competencies:

      • Sound judgment, and strong commitment to ethical conduct and integrity
      • Strong problem solving skills with the ability to identify relevant risks and propose solutions that consider relevant business objectives and compliance concerns
      • Clear and concise interpersonal and verbal communications skills, and the ability to communicate effectively with a variety of personnel at all levels both internally and outside the company
      • Ability to work independently in a fast-paced and dynamic environment
      • High attention to detail, excellent organizational skills, and the ability to work on multiple projects with tight timelines

      Education and Experience:

      • BS/BA with 1-2 years of experience preferred
      • Pharmaceutical/biotech industry preferred
      • Knowledge of applicable laws and industry guidance relating to healthcare and life science, and familiarity with the current life science marketplace (Anti-Kickback, False Claims Act, FDA regulations concerning promotion) preferred

      #LI-RS1

      #Hybrid

  • About the company

      Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology.

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