Insmed Incorporated

Senior Director / Director, Monitoring, Auditing & Risk Management

Location US-NJ-Bridgewater
Job Function

Company Description

About Insmed:


Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.


About the Role:


Can be a Senior Director or Director, depending on experience.   


Reporting directly to the VP of Corporate & Healthcare Compliance, this role will serve as the lead for the Healthcare Compliance Auditing, Monitoring and Risk Management team. The incumbent will guide and direct healthcare compliance auditing and monitoring life cycle, from conducting risk assessment through creation of the annual monitoring and auditing plan through conduct of those activities and creating and assessing results and metrics.   This role will be based at our Bridgewater, New Jersey headquarters location, and remote candidates may be considered.



Additional representative responsibilities will include, but not necessarily be limited to, the following: 


  • Manage global program for compliance risk assessment and management (including development of best practices and guidelines)
  • Support and coordinate compliance risk assessment efforts globally, in partnership with regional Compliance Officers
  • Conduct healthcare compliance monitoring include live activities in the US (e.g. field rides, speaker programs, congresses) and records review globally (e.g. travel & expense, healthcare professional engagements)
  • Conduct healthcare compliance audits in the US (e.g. patient services, speaker’s bureau) and pertaining to global functions (e.g. grants, medical information, publications)
  • Track remediation for all activities
  • Capture and report metrics in a meaningful and engaging manner that helps the Global Compliance Leadership Team and other senior leaders understand Insmed’s global compliance risk profile
  • Lead Enterprise Risk Management activities (assessment, plan, oversight) in conjunction with Insmed’s Operating Committee
  • Create and facilitate presentation to mid-level and senior-level management (e.g. Healthcare Compliance Committee, US Leadership team, etc.)
  • Manage individual contributor direct report by providing coaching, development and guidance


About You:

  • Bachelor’s degree required; advanced degree preferred
  • Compliance certification and auditing certification are a plus
  • At least 10 years’ experience in corporate compliance for a pharmaceutical or biotech company
  • Knowledge of US and global compliance regulations, laws and standards
  • Experience working globally (EMEA, Japan/APAC)
  • Experience in conducting healthcare compliance risk assessments
  • Experience in managing enterprise risk management
  • Experience in conducting healthcare compliance monitoring (live field rides, live speaker programs, records reviews)
  • Experience in conducting healthcare compliance audits
  • Experience in continuous improvement for compliance programs
  • Involvement in creating and presenting presentations for mid-level and senior-level management
  • Involvement in leading and guiding compliance risk assessment, auditing and monitoring strategy
  • Must have excellent communication skills (verbal and written).
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).


Additional Information

Travel Requirements:

  • Domestic and/or International travel required (5-10%)
  • 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.


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