Mirum Pharmaceuticals, Inc.
Creating transformative medicine for people with rare liver disease.
Director, Healthcare Compliance
Location
California
Posted
56 days ago
Salary
$200K - $225K / year
Seniority
Lead
Bachelor Degree7 yrs expEnglish
Job Description
• Lead and manage all aspects of federal and state transparency (Sunshine Act/Open Payments and similar state requirements) and aggregate spend reporting requirements.
• Monitor and analyze data for trends, anomalies and compliance gaps.
• Manage ongoing development and execution of Mirum’s risk-based auditing and monitoring program to ensure compliance with applicable laws, regulations and company policies.
• Work with third-party vendors and internal stakeholders to ensure compliance with state licensing, registration and renewal requirements.
• Manage continual development and implementation of Mirum’s compliance policies.
• Champion Company culture in which employees view compliance as aligned with core values and regard it as a key objective in business decisions and process development.
• Partner with legal, regulatory, finance, quality and other departments to support compliance-related initiatives and resolve operational compliance issues.
• Assist with ongoing management of training curriculum and healthcare compliance training as needed.
• Assist with investigations regarding matters of observed, reported or suspected non-compliance and collaborate with functional heads as needed toward implementing necessary corrective actions.
• Support Privacy initiatives for HIPAA and GDPR compliance as needed.
• Represent Mirum in industry compliance forums.
• Participate in ride-long monitoring activities as needed.
Job Requirements
- Bachelor’s degree required; advanced degree preferred.
- Minimum 7 years of US healthcare compliance experience in a biotech/pharma organization.
- Demonstrated operational compliance expertise, including hands-on experience with transparency reporting, auditing/monitoring and training.
- Familiarity with state and federal licensing and registration requirements.
- Experienced in the development, initiation, maintenance, and enforcement of policies and procedures for the operation of a Compliance Program.
- Demonstrated collaborations working with senior business leaders, attorneys, law enforcement professionals, and regulators.
- Experience in supporting investigations and managing the investigative process.
- Rare disease commercial launch experience preferred but not required.
- Systems implementation/oversight experience preferred.
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