Exelixis, Inc.
Senior Compliance Operations Manager (Finance)
The Senior Compliance Operations Manager will assist in maintaining and enhancing Exelixis' Compliance Program. More specifically, the individual will be responsible for developing, implementing, and supporting healthcare compliance practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. The Company's healthcare compliance audit and monitoring program will be a primary focus for this role, including maintaining the systems needed to enable the company to track and evaluate compliance of its ongoing activities. To that end, this position will be responsible for performing audits of and monitoring of Company interactions with members of the healthcare community and facilitating internal reporting. In addition, this individual will be responsible for evaluation of materials submitted for review and approval, including serving as the owner for COMPASS, the Company's HCP engagement system. Of similar priority will be support of governance committee meetings. The essential business partners for this role are corresponding positions in Sales, Marketing, Market Access, Commercial Operations, Medical Affairs, and HR.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Responsible for the successful implementation and execution of the audit and monitoring program, including development of tools, performance standards, and completion of corrective action. In this role, the individual will need to be a strategic partner to the Commercial and Medical Affairs organizations to ensure that the program evolves as the company grows.
• Works on a range of departmental and/or strategic problems where analysis of situations or data requires critical thinking, an in-depth evaluation, and company knowledge of various factors. May also be required to manage external consultant engagements, when needed, including overall budgets, schedules, and performance standards.
• Acts as a consultant, reviewer and legal/compliance approver as needed, for business activities that involve Healthcare Compliance risks, and contributes to departmental process and organizational improvements and development, including management of the contract request process for HCP engagements. In addition, reviews and approves advisory board meetings, speaker programs, and other Commercial and Medical Affairs activities.
• Supports senior management governance committee meetings (e.g., Ethics Committee and Healthcare Compliance Committee) by presenting compliance updates on key initiatives and reporting metrics from the audit and monitoring program as well as any investigations.
• Supports investigations of potential violations of law or company policy and/or ethical standards related to healthcare ethics and compliance matters, provides competent reports on the results of the investigations, and assists with the determination of corrective actions and the implementation of follow up actions.
• Conducts root cause analyses to understand factors contributing to potential policy violations, develops recommendations, and assists with the design of controls and standards for identified gaps from audit and monitoring activities.
• Develops and facilitates implementation of corrective action protocols for detected deviations from policy or applicable requirements.
• Leverages investigative analytics to share actionable insights with key stakeholders. This includes creating trending analysis and the management and utilization of the investigative case matter management system to drive program improvements and organizational understanding of compliance risks.
• Prepares timely, accurate, and complete reports with corrective action recommendations, including text summaries and graphical presentations of key data, and follow-through with key stakeholders for implementation.
• Assists in the audit and monitoring of company activities, including field ride-alongs, speaker programs, and advisory boards.
• Regularly reviews reports of new compliance developments from governmental agencies such as the OIG and state agencies, including fraud alerts, special advisories or proposed rules and, in conjunction with the legal department, to ensure appropriate interpretation and training regarding such developments.
• Performs other duties as assigned/requested.
SUPERVISORY RESPONSIBILITIES:
• None
EDUCATION/EXPERIENCE/SKILLS:
Education/Certifications:
• BS/BA degree in related discipline and 8 years relevant industry experience, or;
• MS/MA degree in related discipline and 6 years of relevant industry experience; or,
• Equivalent combination of education and/or experience.
• CPA, CIA, CFE, CCEP certifications a plus.
Experience:
• Prior healthcare compliance related investigations experience with demonstrated independent oversight and significant caseload management required. Must have actual experience in conducting and leading investigations from commencement through to conclusion.
• Familiarity with the legal principles of FDA advertising and promotion regulations, the False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required.
• Experience with Polaris software and/or Tableau is a plus.
Knowledge/Skills/Abilities:
• Excellent verbal and written communication skills, must be an effective communicator with strong interpersonal skills
• Strong organizational (detail oriented), project management, and problem-solving skills
• Ability to handle multiple tasks, prioritize appropriately and adapt quickly to new situations, and offer creative solutions to challenging problems
• Must be responsible, conscientious, and professional
• Ability to work under pressure to meet specific deadlines
• Ability to work independently and also be a team player
• Must be able to exercise common sense in carrying out tasks
• Dedication to quality and the highest professional standards
• Must be a self-starter and quick learner
• Must have good judgment
• Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.), Visio, Internet)
• Ability to travel domestically 35%
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.