Director, Audits & Compliance

Job Description

Knowledge:

• Comprehensive knowledge of pharmaceutical contracting, rebate and payment processes, and various market segments (Commercial, Medicaid, ADAP, 340B, Trade).
• Thorough knowledge of SOX principles and processes.
• Excellent cross-functional capabilities within the department, as well as with IT, SOX PMO, Legal, Finance, internal/external auditors, and vendors.
• Extensive Project and Vendor Management experience, including audits (govt pricing preferred), projects, budgets, analyses, and assessments.
• Ability to recognize and interpret business issues/opportunities, analyze, make recommendations, and implement solutions.
• Robust understanding of 340B regulations, legislation, rules, and guidance.
• Strong familiarity with current government legislative issues and regulations.
• Experience with data analysis, systems, and working with IT.

Education & Experience:

• 10+ years of pricing, contracting, and/or systems experience in biotech, pharmaceuticals, or a related industry. BS/BA degree; MBA or advanced degree highly preferred.
• Ability to effectively partner with internal stakeholders to ensure compliant practices across all of Market Access Operations (MAO), Market Access (MA), and internal partners such as SOX PMO, IT, Finance, Legal, as well as external partners such as EY and other project or data analysis vendors.
• Management experience; project management and vendor management experience.
• Strong cross-functional written and oral communication skills at all levels.
• Strong follow up capabilities.
• Independent work ethic combined with a collaboration mindset with A&C, MAO, MA, Gilead, and external partners.

Job Responsibilities:

• Governance and oversight of SOX Audit processes across MAO and MA.
  • Strategic planning and process optimization for the annual SOX audit. Work closely with SOX PMO, internal and external auditors, all MAO teams, and key MA teams. Scope includes controls, processes, documentation, and follow up on action items and recommendations.
  • With A&C team members, coordinate SOX audit activities, including review, update, and enhancement of process controls; review of system application controls with the IT team; calendar flow; training; updates to A&C and MAO leadership.
  • Identify gaps and propose/implement strategic recommendations. In collaboration with MAO teams, establish and implement audits, corrective or preventative action plans (CAPA), monitoring, documentation, and system testing (process/data/systems).

• Audit of government pricing (GP) calculations in collaboration with GP team, external auditor, and Gilead Legal. Includes scope, project management, execution, finalization, summary to management, and follow up on issues.
• Project Management of various MAO initiatives, as needed, related to process, governance, and/or documentation (ex. – integrations, product launches, system updates, new systems).
• Monitor, audit, or assess certain activities or processes across MAO (as determined in Annual Risk Assessment or in routine work).
• Provide support, as needed, to the A&C team on a variety of compliance issues, such as internal or external audits, 340B integrity issues, or data forensic analyses, as needed.
• Compliance Training presentations on key topics in collaboration with Senior Director and A&C team members.
• Regularly review and enhance existing policies, controls, and training to support MAO’s and MA’s understanding and adherence to compliance and SOX.
• Maintain Policies, Procedures, and Work Instructions pertinent to the Director’s areas of responsibility.
• Remain aware of U.S. regulatory changes and market trends; attend conferences, webinars, etc.