Senior Compliance Operations Manager

Exelixis • Alameda, CA

1d • $129,000 - $183,000

About The Position

The Senior Compliance Operations Manager will assist in maintaining and enhancing the organization’s Compliance Program. This 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. This individual will be responsible for evaluation of materials submitted for review and approval, including serving as the owner of the company’s HCP engagement system. This role requires data-driven analysis and familiarity with Physician Payments Sunshine Act (Open Payments) transparency reporting requirements, strong investigative capabilities, and expertise in conducting risk assessments, audits, and monitoring activities. The essential business partners for this role are corresponding positions in Sales, Marketing, Market Access, Commercial Strategy, Analytics & Operations, Medical Affairs, Information Technology (IT), Legal Affairs and Human Resources (HR).

Requirements

• Bachelor’s degree in related discipline and 9 years of related experience; or MS/MA degree in related discipline and 7 years of related experience; or Equivalent combination of education and experience
• Experience in the pharmaceutical and biotech industries.
• Specific expertise in the best practices of healthcare compliance and auditing.
• Familiarity with the legal principles of FDA advertising and promotion regulations, the False Claims Act, Anti-Kickback Statute, Physician Payments Sunshine Act (Open Payments), OIG guidance, and the PhRMA Code required.
• 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%

Nice To Haves

• Healthcare Compliance Certificate a plus.
• Finance audit experience is a plus.
• Experience with SteepRock HCP engagement system, audit & monitoring platforms, and/or Tableau is a plus.

Responsibilities

• Responsible for the support and execution of the audit and monitoring program, including development of tools, performance standards, and completion of corrective action.
• Assists in the audit and monitoring of HCP-related company activities.
• Review business requests for sponsorships and exhibits.
• Maintain robust repository of analysis and reports.
• Assist with live and online training activities and collection and maintenance of company training data.
• Conducts bench testing/auditing of business activities to confirm that compliance controls are operating effectively.
• Leverages data analytics and investigative techniques to identify compliance trends, assess risks, and share actionable insights with key stakeholders.
• Serves as back up support for aggregate spend tracking and reporting activities, including managing the process for collecting, reviewing, and validating data for CMS Open Payments submissions.
• Maintains current knowledge of federal and state transparency laws and requirements.
• 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.
• Owns and administers the HCP engagement management system (e.g., ETHOS/SteepRock), including system configuration, user access management, workflow optimization, and ensuring data integrity across all compliance tracking processes.
• Maintains understanding of AI applications and data management best practices in compliance operations, including how machine learning can support benchmarking, pattern detection in HCP engagement data, and automated compliance monitoring.
• Supports business stakeholders with day-to-day compliance activities, including reviewing HCP engagement requests, conducting FMV assessments, and managing payment tracking and reporting workflows.
• Performs other duties as assigned/requested.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level