Executive Director, Compliance Monitoring and Auditing

Insmed   •  

Bridgewater, NJ

11 - 15 years

Posted 266 days ago

This job is no longer available.

Job Description

SUMMARY:

This position will have leadership responsibility for all aspects of US Healthcare Compliance monitoring and for all aspects of US Healthcare Compliance auditing and risk assessment.

This position requires extensive subject-matter expertise in US Healthcare Compliance, which will be the area of initial focus, with bandwidth to expand to Global Healthcare Compliance and GxP Compliance. This role reports to the Chief Compliance Offer and will be based in our Bridgewater, New Jersey headquarters.

RESPONSIBILITIES:

  • Developing and implementing a US Healthcare Compliance Monitoring Program, both live and paper-based, in all relevant areas including ride-alongs, attendance at speaker programs and advisory boards and attendance at congresses, as well as monitoring travel and expense, HCP and payor interactions, Medical Affairs including medical information requests, and publications support.  This includes active participation in all of these activities.
  • Developing and implementing a US Healthcare Compliance Auditing Program including all aspects of promotional activities, Medical Affairs, commercial/medical interactions, payor interactions, patient interactions, Healthcare Professional (HCP) interactions, disease awareness, patient support, patient assistance, government pricing and specialty pharmacies.
  • Developing and implementing a Compliance Risk Assessment Process.
  • Working with the Executive Director, Corporate Compliance, Policies and Training, on designing auditing and monitoring programs to ensure robust implementation of corporate compliance policies and training.
  • Assisting the Chief Compliance Officer on matters as assigned.
  • Key relationships:  Legal, Commercial, Sales & Marketing, Medical Affairs, Human Resources, Finance, Quality, Regulatory Affairs, Clinical Quality Assurance

Qualifications

REQUIREMENTS:

  • Graduate degree in a relevant area (Finance, MBA, statistics) required..Healthcare compliance certification is also preferred
  • A minimum of 12years of experience in a Compliance role, a substantial portion of which has been in a global life sciences company
  • Extensive subject-matter expertise in US Healthcare Compliance, which will be the initial area of focus, with bandwidth to expand to Global Healthcare Compliance and GxP Compliance.
  • Proactive, hands-on approach
  • Very execution-oriented
  • Ability to maintain numerous work streams simultaneously
  • Unquestioned ethics and integrity
  • Able to work independently 
  • Creative and innovative thinker
  • Well-organized with strong analytical skills
  • Outstanding written and verbal communications skills
  • Ability to interact well with all levels including senior leadership