Mineralys Therapeutics - Associate Director - Compliance
Requirements
• 8 or more years of compliance or compliance operations experience in the pharmaceutical industry • Demonstrated experience building or significantly enhancing a pharmaceutical compliance program, including policy development, training, monitoring, and investigations • Meaningful experience with HCP engagement programs, including needs assessment review, FMV processes, and professional services agreement compliance • Experience with compliance risk assessment methodologies and monitoring program design and execution • Proven ability to serve as a trusted advisor and business partner to commercial, clinical, medical, and operational stakeholders. • Core Competencies • Core Competencies • Deep expertise in pharmaceutical compliance requirements, including the Anti-Kickback Statute, False Claims Act, Sunshine Act/Open Payments, PDMA, PhRMA Code, and applicable OIG guidance • Comprehensive understanding of HCP engagement compliance requirements at both the federal and state levels • Exceptional written and verbal communication skills, including the ability to present complex compliance matters clearly and concisely • Demonstrated ability to build collaborative, trusted relationships across functions while maintaining appropriate independence and objectivity • Strong analytical and critical-thinking skills, with the ability to assess risk, synthesize information, and draw sound, well-reasoned conclusions • Solutions-focused, approachable mindset that enables compliant business outcomes while upholding the highest ethical standards • High degree of professional integrity, discretion, and personal accountability • Travel • This position requires up to 10% travel. Frequently travel is outside the local area and overnight. • This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
Responsibilities
• Partner with compliance lead to build, refine, and continuously mature a best-in-class compliance program aligned with OIG guidance, industry standards and best practices, and Mineralys’ strategic priorities • Draft, implement, and periodically refresh compliance policies, standard operating procedures, and related guidance documents • Manage the end-to-end policy lifecycle, including stakeholder review and communication of policy updates to affected personnel • Design, develop, and administer a comprehensive compliance training program that supports ongoing education and reinforces a strong compliance culture. • Partner with business to manage Mineralys’ healthcare professional (HCP) engagement program • Evaluate proposed HCP engagements for legitimate business need, appropriate fair market value (FMV) compensation, and consistency with legal and regulatory requirements • Implement a risk-based compliance monitoring program that evaluates adherence to policies and procedures across high-risk business activities • Support the management and resolution of compliance investigations ensuring timely, consistent, and well-documented outcomes. • Take on strategic compliance projects and initiatives, including support for privacy matters • Perform benchmarking and research on emerging compliance topics, regulatory developments, and industry best practices to inform program strategy
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