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Associate Director – Compliance
MDWerks Inc.Compliance professional building and operationalizing compliance program for Mineralys Therapeutics focused on hypertension and related diseases. Collaborate with compliance lead and stakeholders to enforce a culture of integrity.
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- medical
- dental
- vision
- time off
- 401K
- participating in Mineralys incentive plans
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Compliance Policy DevelopmentCompliance Monitoring Program DesignCompliance Investigations ManagementFair Market Value AssessmentRegulatory ComplianceStakeholder CommunicationRisk-Based Compliance MonitoringBenchmarking and ResearchStandard Operating ProceduresOIG Guidance Alignment
Soft Skills
Trusted AdvisorBusiness PartneringStrategic ThinkingCollaborationCommunication