Associate Director – Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with the compliance lead to establish, enhance, and continually improve a top-tier compliance program that aligns with OIG guidance, industry standards, best practices, and Mineralys' strategic objectives.

• Create, implement, and periodically update compliance policies, standard operating procedures, and associated guidance documents.

• Oversee the complete policy lifecycle, including stakeholder reviews and communicating policy updates to relevant personnel.

• Design, develop, and manage a comprehensive compliance training program that promotes ongoing education and strengthens a robust compliance culture.

• Collaborate with the business to oversee Mineralys' healthcare professional (HCP) engagement program.

• Assess proposed HCP engagements for legitimate business justification, appropriate fair market value (FMV) compensation, and alignment with legal and regulatory standards.

• Implement a risk-based compliance monitoring program that assesses adherence to policies and procedures within high-risk business activities.

• Assist in the management and resolution of compliance investigations, ensuring outcomes are timely, consistent, and well-documented.

• Undertake strategic compliance projects and initiatives, including support for privacy issues.

• Conduct benchmarking and research on emerging compliance topics, regulatory changes, and industry best practices to guide program strategy.

⛳️ Requirements

• A minimum of 8 years of experience in compliance or compliance operations within the pharmaceutical industry.

• Proven experience in developing or significantly enhancing a pharmaceutical compliance program, encompassing policy development, training, monitoring, and investigations.

• Substantial experience with HCP engagement programs, including conducting needs assessments, FMV processes, and ensuring compliance with professional services agreements.

• Familiarity with compliance risk assessment methodologies and the design and execution of monitoring programs.

• Established ability to act as a trusted advisor and business partner to commercial, clinical, medical, and operational stakeholders.

🏝️ Benefits

• Medical

• Dental

• Vision

• Time off

• 401K

• Participation in Mineralys incentive plans