Mineralys Therapeutics

Mineralys Therapeutics is revolutionizing hypertension treatment with lorundrostat, a targeted therapy that normalizes aldosterone levels to reduce the risk of stroke, kidney damage, and heart failure.

Pharmaceuticals

Health Care

11-50 (20)

Founded 2020

$162M raised

13 open positions

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Associate Director - Compliance

2 days, 11 hours ago

United States

Full-time

Lead

Compliance Manager

Operations

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Mineralys Therapeutics

Pharmaceuticals

11-50

Founded 2020

$162M raised

View All Jobs 13

Description

Partner with the Compliance Lead to build, refine, and mature a best-in-class compliance program aligned with OIG guidance, industry standards, and company priorities.
Draft, implement, and update compliance policies, standard operating procedures, and related guidance documents.
Manage the policy lifecycle, including stakeholder review and communication of policy changes to affected personnel.
Design, develop, and administer a comprehensive compliance training program.
Partner with the business to manage the company’s healthcare professional engagement program.
Review proposed HCP engagements for business need, fair market value compensation, and regulatory compliance.
Implement a risk-based compliance monitoring program across high-risk business activities.
Support the management and resolution of compliance investigations and ensure well-documented outcomes.
Lead strategic compliance projects and initiatives, including support for privacy matters.
Perform benchmarking and research on emerging compliance topics, regulatory developments, and industry best practices.

Requirements

8 or more years of compliance or compliance operations experience in the pharmaceutical industry.
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.
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, including the ability to present complex compliance matters clearly and concisely.
Strong analytical and critical-thinking skills with the ability to assess risk, synthesize information, and draw sound conclusions.
Up to 10% travel, including overnight travel outside the local area.

Benefits

Fully remote work environment.
Medical, dental, and vision benefits.
Time off benefits.
401(k) plan.
Eligibility for company incentive plans contingent on personal and company performance.
US salary range of $150,343 to $192,670.

Interested in this position?

Apply directly on the company website

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