Associate Director, Legal-Compliance

About this role

Department: 101400 Legal Location: San Diego Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients .

The Associate Director, Legal-Compliance, will support the ongoing execution and enhancements of Travere’s healthcare Compliance Program to guide and support Commercial, Medical Affairs, Patient Advocacy, and other external-facing teams’ initiatives.  

The role will have primary responsibilities for monitoring and auditing – including planning, execution, data and trend analysis, and reporting of efforts and findings. The role will also support projects and tasks across the Compliance Program’s Seven Elements, including drafting policies, guidance communications, training, and developing AI tools that improve Compliance Operations.

The role requires a detail-oriented, analytical individual.  The role also requires the ability to partner cross-functionally to collaborate, identify synergies and trends, improve controls, and promote a culture of compliance.

The ideal candidate will have a strong working knowledge of applicable healthcare laws, regulations, and industry codes, including but not limited to the Anti-Kickback Statute, False Claims Act, OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Professionals, and other applicable federal and state requirements.

Responsibilities: Support operational planning and project management to continuously align Travere’s healthcare Compliance Program with the company’s strategic plans and tactics.

​ Planning and Project Management: • Co-lead annual and periodic assessments of the Seven Elements Compliance Program, identifying emerging risks and recommending strategic priorities for the Compliance Program roadmap.

• Develop and maintain project plans to support Compliance Program, and related projects.

• Enhance, develop, and maintain monitoring and auditing plans, playbooks, templates, trackers, reporting cadence, and reporting documents.

• Lead day-to-day operations and execution of compliance monitoring and auditing activities for Travere’s healthcare Compliance Program to support the Company’s strategic plans and tactics.

Live Monitoring: • Oversee and coordinate with live monitoring vendors and other Travere colleagues to meet annual live monitoring plan goals.

• Conduct live monitoring of external-facing activities – including HCP interactions, speaker and other educational programs, advisory boards, field activities, and patient-facing activities.

Data Analytics Audits: • Use data analytics dashboards and operational reports to identify trends, outliers, potential policy deviations, repeat issues, and emerging risk areas across field teams and business functions.

• Oversee and coordinate with data analytics vendor to ensure timely data exchanges and refreshes and the accuracy of data and mapping files.

• Coordinate with other Travere teams to collect and manage data and to identify new data sources.

Collaboration and Enhancements: • Collaborate with other Travere operations teams – including Commercial Operations and Medical Operations – Travere’s Digital Innovation team, and those teams’ vendors, to identify additional data, analytics, and process synergies.

• Identify opportunities to enhance data analytics dashboards, processes, and reporting based on industry enforcement/guidance and/or Travere identified needs.

Other Audits: • Based on routine compliance assessments, identify and conduct data-driven audits across relevant systems and data sources, including customer relationship management systems, expense data, transparency/transfer-of-value data, and other documentation repositories.

• Reporting:

• Prepare clear, accurate, and high-quality Compliance monitoring and auditing reports for presentation to the Compliance Committee, and other senior leaders.

Follow Up, Corrective Action: • Follow up with field leaders and field colleagues on potential findings, feedback, and to track assigned corrective action, when applicable.

• Translate monitoring and audit insights into recommended updates to policies, SOPs, field guides, training, communications, controls, and business processes.

Vendor Oversight: • Manage or coordinate vendors supporting monitoring, auditing, analytics, and field monitoring activities, including oversight of quality, timelines, budget tracking, and deliverables.

Drive Compliance Program,  processes, and systems enhancements:

Policy, SOP, Communications, and Training: • Draft, or enhance existing, policies, training, and other resources that translate policies and procedures into practical and easy to understand guidance for employees.

• Manage the related policy plans, stakeholder reviews, and approval documentation.

Compliance Program Operations and AI • Advise and support the continuous improvement of Compliance Operations processes and systems, including enhancing documentation, tracking tools, reporting templates, and opportuni

Similar jobs

• Associate Director, Legal & Compliance — Amylyx · Cambridge, MA
• Associate Director, Compliance — Cogentbiosciences · Waltham, Massachusetts, United States
• Director, Legal Compliance — Mastercard · Purchase, New York
• Associate Director, Corporate Compliance — Oscar · New York, New York, United States
• Associate Director, Corporate Compliance — Oscar · Remote
• Associate Director, Corporate Compliance — Oscar · Remote
• Associate Director, Corporate Compliance — Oscar · Tempe, Arizona, United States
• Senior Director, Legal and Compliance Operations — Madrigalpharma · Remote