Director, Compliance Business Partner
Insmed Incorporated
6 hours ago
Remote friendly (Bridgewater, NJ)
United States
Corporate Functions
Director, US Compliance – Business Partner
What You'll Do
- Collaborate with key internal functions and cross-functional stakeholders to embed Compliance as a strategic enabler throughout program development and business growth.
- Serve as a dedicated Compliance partner to Neuro & Other Rare Program Teams, providing proactive, risk-based guidance on applicable laws, regulations, and industry standards as programs advance through clinical development and commercialization; address gene therapy and rare disease compliance considerations (including patient access, expand access programs, and interactions with healthcare professionals).
- Extend Compliance guidance and support to other Program Teams (as assigned) across the product lifecycle (clinical trials, launch, post-market); foster a culture of compliance via proactive stakeholder engagement, targeted training, review of materials, and practical business-oriented solutions to compliance challenges.
- Attend cross-functional team meetings and foster stakeholder engagement.
- Oversee implementation of mitigation plans and processes to follow up on and close out compliance issues identified by monitoring and auditing; support the Internal Investigation Committee as needed.
- Review materials and other activities for functional areas as assigned.
- Develop and facilitate Compliance training (e-learning and live) for functional areas assigned.
- Develop, review, and update Compliance policies and SOPs; represent Compliance on functional review of SOPs.
- Support proactive compliance focused on partnerships, prevention, and risk mitigation; develop plans and deliverables to inform internal functions.
- Raise awareness of the Compliance program and foster accountability.
- Promote continuous improvement and propose enhancements to the Compliance Program.
Who You Are (Qualifications)
- Minimum Bachelor’s degree in a related field.
- 10+ years’ experience in US Healthcare, with significant US HCC experience (pharmaceutical/biotech), including experience in at least some of: project management, learning & training, quality management system, auditing/monitoring, data analytics, policy/SOP development, risk assessment, and investigations.
You Are Or You Have (Required/Preferred)
- In-depth knowledge of applicable HCC laws and guidance, including OIG guidelines, AMA guidelines, PhRMA Code, Corporate Integrity Agreements, Anti-Kickback, False Claims Act, and US transparency laws/reporting processes.
- Highly preferred: direct, hands-on experience in a Gene Therapy organization with familiarity with unique US compliance risks.
- Proven experience building/implementing/managing an effective compliance program in a growing commercial biotech environment, ideally with product launch experience.
- Experience in continuous improvement for compliance programs.
- Ability to collaborate effectively with diverse cross-functional teams and senior leadership.
- High ethical standards and integrity/sound judgment.
Nice to Have
- HCC certifications.
Travel Requirements
- Occasional travel (approximately 5%–15%).
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
What You'll Do
- Collaborate with key internal functions and cross-functional stakeholders to embed Compliance as a strategic enabler throughout program development and business growth.
- Serve as a dedicated Compliance partner to Neuro & Other Rare Program Teams, providing proactive, risk-based guidance on applicable laws, regulations, and industry standards as programs advance through clinical development and commercialization; address gene therapy and rare disease compliance considerations (including patient access, expand access programs, and interactions with healthcare professionals).
- Extend Compliance guidance and support to other Program Teams (as assigned) across the product lifecycle (clinical trials, launch, post-market); foster a culture of compliance via proactive stakeholder engagement, targeted training, review of materials, and practical business-oriented solutions to compliance challenges.
- Attend cross-functional team meetings and foster stakeholder engagement.
- Oversee implementation of mitigation plans and processes to follow up on and close out compliance issues identified by monitoring and auditing; support the Internal Investigation Committee as needed.
- Review materials and other activities for functional areas as assigned.
- Develop and facilitate Compliance training (e-learning and live) for functional areas assigned.
- Develop, review, and update Compliance policies and SOPs; represent Compliance on functional review of SOPs.
- Support proactive compliance focused on partnerships, prevention, and risk mitigation; develop plans and deliverables to inform internal functions.
- Raise awareness of the Compliance program and foster accountability.
- Promote continuous improvement and propose enhancements to the Compliance Program.
Who You Are (Qualifications)
- Minimum Bachelor’s degree in a related field.
- 10+ years’ experience in US Healthcare, with significant US HCC experience (pharmaceutical/biotech), including experience in at least some of: project management, learning & training, quality management system, auditing/monitoring, data analytics, policy/SOP development, risk assessment, and investigations.
You Are Or You Have (Required/Preferred)
- In-depth knowledge of applicable HCC laws and guidance, including OIG guidelines, AMA guidelines, PhRMA Code, Corporate Integrity Agreements, Anti-Kickback, False Claims Act, and US transparency laws/reporting processes.
- Highly preferred: direct, hands-on experience in a Gene Therapy organization with familiarity with unique US compliance risks.
- Proven experience building/implementing/managing an effective compliance program in a growing commercial biotech environment, ideally with product launch experience.
- Experience in continuous improvement for compliance programs.
- Ability to collaborate effectively with diverse cross-functional teams and senior leadership.
- High ethical standards and integrity/sound judgment.
Nice to Have
- HCC certifications.
Travel Requirements
- Occasional travel (approximately 5%–15%).
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.