Join the World's Top Legal Talent Network

Summary/Job Purpose

The Associate Director, Compliance Operations will assist in maintaining and enhancing Exelixis Compliance Program. More specifically, the individual will be responsible for developing, implementing, communicating and maintaining healthcare compliance policies, practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. The focus will be on managing a policy strategy, including policy development and associated ethics and compliance training, and supporting compliance-related investigations as well as implementation of corrective actions. The Senior Compliance Operations Manager must also have knowledge of, and experience in, conducting compliance auditing & monitoring activities. The essential business partners for this function are corresponding positions in Sales, Marketing, Market Access, Medical Affairs, HR, and Finance.

Essential Duties And Responsibilities

• Promote ethics & compliance under Exelixis’ Compliance Program through identification of compliance policy and training needs and development of new and enhanced compliance program activities.
• Lead and assist in developing and delivering effective and creative training, including written materials, computer-based instruction, and live presentations that leverage adult learning principles and foster greater engagement. This work will require periodic review and standardization of the ethics & compliance training curriculum to ensure consistency and the use of effective teaching methods.
• Serve as department administrator of the company learning management system and develop innovative compliance tools (e.g., game-based training), aids, and resources to guide ethical decision-making and behavior.
• Collaborate with key functional area stakeholders to identify risks and issues that may require training and monitoring, and ensure maintenance of policies, processes and investigative protocols on an ongoing basis.
• 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.
• Support investigations of potential violations of law or company policy and/or ethical standards related to healthcare ethics and compliance matters, provide competent reports on the results of the investigations, and assist with the determination of corrective actions and the implementation of follow up actions.
• Conduct root cause analysis to understand factors contributing to potential policy violations, develop recommendations, and assist with the design of controls and standards for identified gaps from audit and monitoring activities.
• Develop and facilitate implementation of corrective action protocols for detected deviations from policy or applicable requirements.
• Leverage 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.
• Prepare 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.
• Assist in the audit and monitoring of company activities, including field ride-alongs, speaker programs, and advisory boards.
• Perform other duties as assigned/requested.

Supervisory Responsibilities

• NONE

Education/Experience

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• BS/BA degree in related discipline and 10 years relevant industry experience, or;
• MS/MA degree in related discipline and 8 years of relevant industry experience; or,
• Equivalent combination of education and/or experience.
• CPA, CIA, CFE, CCEP certifications a plus.

Experience/The Ideal For Successful Entry Into Job

• Prior training experience with demonstrated creativity in training programs required.
• 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

• 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

_If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

_ Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $169,500 - $239,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

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.

_