Director, Compliance

Mineralys Therapeutics

Mineralys Therapeutics, a clinical-stage biopharmaceutical company, seeks a Director of Compliance to build and operationalize its compliance program. The role involves developing policies, managing training initiatives, overseeing healthcare professional engagement oversight, and leading compliance monitoring efforts while reporting to the Vice President of Compliance.

Responsibilities

Build, refine, and mature a best-in-class compliance program aligned with OIG guidance and industry standards
Develop, draft, and implement healthcare compliance policies, procedures, and guidance documents
Design and administer comprehensive compliance training program
Evaluate proposed HCP engagements for legitimate business need and FMV compliance
Support implementation of risk-based compliance monitoring and investigation resolution

Requirements

Bachelor's degree; relevant professional certification (CHC, CCEP) preferred
12+ years of compliance or compliance operations experience in pharmaceutical industry
Demonstrated experience building or significantly enhancing pharmaceutical compliance programs
Meaningful experience with HCP engagement programs and FMV processes
Experience with compliance risk assessment methodologies and monitoring program design
Deep expertise in Anti-Kickback Statute, False Claims Act, Sunshine Act, and OIG guidance

Apply

Vacancy posted 14 days ago

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