Executive Director, Compliance Monitoring and Auditing
- 10 Finderne Ave, Bridgewater, NJ 08807, USA
Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
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.
- 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
- Graduate degree in a relevant area (Finance, MBA, statistics) required..Healthcare compliance certification is also preferred
- A minimum of 12 years 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
Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.