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Salary: USD 175,000 - 190,000 / annual
Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing medicines to treat hypertension and related conditions including chronic kidney disease, obstructive sleep apnea, and aldosterone-driven diseases. The company is fully remote and headquartered in Radnor, Pennsylvania.
The Senior Manager, Compliance Operations plays a key role in operationalizing and sustaining Mineralys' compliance program across the organization. This role partners closely with commercial, medical, and corporate functions to embed a culture of ethical behavior and regulatory accountability. The position reports to the Vice President, Compliance.
Key responsibilities include:
• Support implementation and optimization of aggregate spend and transparency reporting systems and processes to ensure compliance with federal and state laws (Sunshine Act/Open Payments, state transfer of value). Develop and maintain data governance protocols, reconciliation processes, and quality controls to ensure data integrity. Serve as main business owner and liaison to IT and vendor partners. Prepare and support submission of aggregate spend reports to government agencies and internal leadership.
• Support external funding requests including corporate sponsorships, memberships, independent medical education, and research grants. Serve as internal subject matter expert on external funding compliance requirements. Administer review and approval processes to ensure alignment with regulations, company policies, and fair market value standards.
• Support Mineralys' compliance sample accountability program in accordance with the Prescription Drug Marketing Act (PDMA) and applicable state regulations. Liaise with sample accountability vendor, field sales, and commercial operations. Coordinate periodic sample inventories, investigate discrepancies, and implement corrective actions. Maintain accurate records and produce reports for internal review and regulatory submissions.
• Assist in development, design, review, and delivery of healthcare compliance policies, standard operating procedures, and training programs consistent with regulatory guidance and industry best practices (PhRMA Code, OIG guidance, aggregate spend, third-party funding, sampling, code of conduct).
• Support compliance function in identifying gaps and proactively developing resources to address compliance risk areas. Provide practical, solutions-oriented guidance enabling compliant business activities. Support special projects and initiatives.
Travel: Up to 10% travel required, frequently outside local area and overnight.
QUALIFICATIONS:
• Bachelor's degree required; relevant professional certification (CHC, CCEP) preferred
• 5+ years of progressive experience in healthcare or pharmaceutical compliance, with at least 2 years in a role with direct responsibility for transparency/aggregate spend reporting
• Demonstrated experience managing third-party funding processes (grants, sponsorships, memberships) within a pharmaceutical or life sciences organization
• Hands-on experience with aggregate spend technology platforms (e.g., Veeva Vault, Concur, MedPro, Medispend, Porzio, or comparable systems)
• Familiarity with PDMA sample accountability requirements strongly preferred
• Experience administering compliance training programs and working within an LMS (e.g., Veeva Vault Training, Cornerstone, or similar)
• Deep working knowledge of Sunshine Act/Open Payments regulations, state transfer of value laws, and applicable OIG guidance
• Strong understanding of the PhRMA Code
• Excellent analytical and problem-solving skills with strong attention to detail and data accuracy
• Ability to translate complex regulatory requirements into practical operational guidance for business stakeholders
• Strong project management skills with ability to prioritize and manage multiple workstreams simultaneously
• Outstanding written and verbal communication skills; ability to present compliance information clearly to diverse audiences
• Demonstrated ability to build trusted relationships and influence without direct authority
• High degree of professional integrity, sound judgment, and collaborative, solutions-focused mindset
