The Ethics and Compliance Audit Manager independently develops healthcare compliance audit plans, conducts internal routine and ad hoc audits for healthcare compliance and ethics requirements, Roche policies and procedures. This position continuously monitors, communicates, and maintains highest level of awareness with current industry standards, emerging regulations, and guidance to ensure proactive determination of compliance risk.
Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
- Develop audit strategy and compliance audit plan integrating compliance risk/context, business knowledge, and an understanding of database reporting capabilities.
- Executes routine and ad hoc compliance audits of functional processes across various departments to ensure adherence to healthcare compliance and ethics policies, guidelines, and SOPs.
- Summarizes and communicates audit progress and findings to various levels of management, both live and in written materials.
- Designs, delivers, and oversees effective corrective action plans and/or risk mitigation in partnership with cross-functional stakeholders; tracks to ensure that corrective action plans are completed on a timely basis.
- As assigned, assists with other compliance projects related to areas such as operations, investigations, policy, and transparency.
Who you are:
- Bachelors degree in related field and 8+ years of related experience OR 12+ years of related experience
- Excellent problem solving, customer service, negotiation, interpersonal, decision making, leadership, and communication skills
- Highest level of knowledge of industry, quality and regulatory standards
- High level of knowledge of business operations
- Excellent organizational, decision-making, human relations and communication skills
- Ability to resolve problems in a timely manner
- Professional certification (CPA, CIA, etc.)
- Knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the diagnostic and/or pharma industry (includes anti-kickback statutes, government fraud and abuse, off-label promotion, AdvaMed/PhRMA Code, etc.).
- Three or more years of work experience in auditing, compliance, consulting, legal, or investigations (Big 4 accounting firm, consulting firm, or diagnostics/pharma industry related experience preferred).
- Highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications.
- Excellent project management skills
Roche is an equal opportunity employer.Audit & Compliance, Audit & Compliance > General Compliance