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The Compliance Operations Manager will support the development, implementation, and continuous improvement of healthcare compliance practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. One primary responsibility will be assisting in the management of the process for tracking and reporting HCP spend, including assessing global transparency reporting requirements. This position will also evaluate materials submitted for review and approval, perform audits, and conduct training related to interactions with the healthcare community. Of similar priority will be supporting the Company’s healthcare compliance monitoring program. The essential business partners for this function are corresponding positions in Commercial, Development, Medical Affairs, IT, Legal, and Finance.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
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.
Supports processes related to fulfillment of the company’s HCP spend tracking and reporting obligations under the ACA’s Sunshine Act provisions and related state laws regulating HCP spend by drug manufacturers or requiring state tracking and reporting.
Applies technical expertise in the arena of data analytics and supports goals with an understanding of priority and impact to the HCP spend tracking and reporting program, compliance department and organization.
Collaborates with Legal colleagues on global transparency reporting requirements to determine applicability to Exelixis business activities and supports building of infrastructure to enable compliance with those requirements as the company continues to grow and advance its pipeline.
Participates in industry workgroups, remaining current on new and proposed reporting laws and regulations and supports operationalization of new or enhanced processes to enable compliance.
Supports execution of the audit and monitoring program, including development and application of tools, performance standards, and completion of corrective action.
Leverages data analytic skills proactively to address potential healthcare compliance issues and thereby prevent or minimize compliance risk to the company. Works with internal stakeholders to achieve business goals within a compliance framework.
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.
SUPERVISORY RESPONSIBILITIES:
None
EDUCATION/EXPERIENCE/SKILLS:
Education:
BS/BA degree in related discipline and seven years of related experience; or,
MS/MA degree in related discipline and five years of related experience; or,
Equivalent combination of education and/or experience.
Experience:
Healthcare compliance auditing and monitoring experience required. Finance audit experience is a plus.
Experience with global transparency reporting requirements required.
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 SteepRock HCP engagement system, Veeva, and 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 25%
JOB COMPLEXITY:
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
Networks with key contacts outside own area of expertise.
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.
