Associate Director - Compliance
New
M
Mineralys TherapeuticsBiopharmaceutical
US RemoteFull-TimeSenior
Salary$150,343 - $169,384
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Job Details
- Experience
- 8 or more years of compliance or compliance operations experience in the pharmaceutical industry
- Required Skills
- 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.
- 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.
- Strong analytical and critical-thinking skills.
- Ability to travel up to 10%, frequently outside the local area and overnight.
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, evaluating proposed engagements for legitimate business need, fair market value (FMV) compensation, 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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