Senior Manager, Compliance Monitoring

Senior Manager, Compliance Monitoring
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Senior Manager, Compliance Monitoring

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

About the Role

We are seeking a Senior Manager of Compliance Monitoring to assist in enhancing and operating Gilead's healthcare compliance monitoring program. The ideal candidate is an experienced risk management professional from the biotech and/or pharmaceutical industry. Ideally the successful candidate will have gained exposure to working within a multi-national organization with a U.S.-based headquarters. The candidate must have a strong background and exposure to compliance-related monitoring and auditing, compliance-related systems, with experience in change management to support effective enhancement of Gilead operations.

Location: Foster City, California

Essential Duties and Job Functions:

This individual will support the Global Compliance Monitoring Director to lead effective monitoring and oversight of company business activities in compliance with relevant laws, regulations, and policies. Such monitoring and oversight activity will include leveraging of data analytics, risk-based sampling, support of potential investigations and complaints, and assessing observations of various activities & events to identify potential areas of focus.

The individual will work closely with colleagues within the Legal and Compliance organizations and across different functions, including key partners such as IT, Commercial, Development, Medical Affairs, Public Affairs, Government Affairs, Finance and Clinical, among others, to leverage information from relevant systems for identification and addressing of potential compliance-related issues. Additionally, the role will work closely with the affiliates and the local legal teams across the organization to support the monitoring program.

A key goal of this position is to help drive innovation and consistency in our approach to compliance-related monitoring outside the U.S. to ensure both Gilead and industry best practices are shared and adopted across geographies and functions.

Responsibilities:
Support the Global Compliance Monitoring Director in partnering with colleagues across Legal and Compliance, including affiliate Legal teams and various business functions to develop and align on a multi-faceted monitoring strategy by using outlets such as data analytics, robotics, and artificial intelligence from relevant systems & platforms, live observation of various activities and events, and other risk-based strategies.
Drive the timely development and propagation of ongoing enhancements to the company's healthcare compliance monitoring program, which shall be informed by an annual risk assessment.
Ensuring the carrying out of the global monitoring plan with special focus on areas of historic risk, data anomalies, complaints, and other priorities raised by leadership, as well as tracking and reporting timely remediation as applicable.
Execute monitoring from end-to-end, including the ability to independently plan, execute, and report on monitoring activities. This will comprise of creating comprehensive project plans that define objectives, scope, and methodologies, as well as developing interview guides and monitoring checklists to ensure alignment with relevant policies, risk assessment results, and other compliance and business factors.
Collaborate with other various business functions to ensure timely and appropriate action is taken to address potential risks and issues identified through periodic risk assessments and compliance monitoring.
Collaborate with the Compliance Analytics and Systems team as well as the Transparency team and IT to support the evolution of the company's compliance-related systems for improved data capture, automation, data analytics, robotics, and artificial intelligence algorithms important to monitoring compliant business activity.
Perform data monitoring, identifying trends and potential compliance issues through various methods such as live and process monitoring, and effectively communicating preliminary observations. Additionally, generate detailed monitoring reports that document objectives, approaches, observations, and recommendations, and clearly presenting these monitoring results to leadership and key stakeholders.
Partner with various business functions to explore ways in which monitoring-related data may be used to support business strategy and objectives in a compliant manner.
Partner with various business functions and compliance colleagues to understand new and emerging business trends for collaborative design of monitoring plans.
Support various business functions in designing business-led monitoring approaches of both higher risk activities and third parties.
Use broad strategic thinking to analyze the characteristics of the legal, enforcement, and business environment, and identify methods of adapting monitoring to meet those characteristics.
Foster an energizing work environment where employees have impact on our patient-centric mission and can grow their careers.

Minimum Requirements:
Bachelor's degree required.
4-5+ years of relevant prior pharmaceutical or biotechnology industry experience, including professional experience advising on anti-kickback/anti-bribery laws and other compliance mandates.
Excellent verbal and written communication skills
Able to exercise judgment and propose courses of action where precedent may not exist.
In-depth understanding of business objectives and how those translate into healthcare compliance priorities to deliver advice and guidance to the business.
Experience with structures and concepts that facilitate an efficient and effective compliance program. Experience with conducting healthcare compliance monitoring and implementing a monitoring program.
Ability to plan a monitoring activity with little to no oversight (i.e., create a project plan that clearly identifies the objective, scope, and monitoring approach; can generate an interview guide that helps facilitate discussions to better understand the risk associated with processes, and create monitoring checklists that capture key controls which aligns to the expectations of applicable policies)
Ability to execute a monitoring activity with little to no oversight (i.e., perform data monitoring and analyze data for trends, outliers, and compliance with applicable policies; perform live monitoring to identify compliance issues through in-person or virtual review of an activity; perform process monitoring to identify compliance issues through documentation review of an activity, and ultimately share and validate preliminary observations with the business)
Ability to report on a monitoring activity with little to no oversight (i.e., create a monitoring report that clearly documents the objective, approach, observations, recommendations, and clearly present the objective, approach, and results of the monitoring report)
Excellent interpersonal and influencing skills, an inquisitive mind, and the ability to work effectively in a global, matrixed organization with multiple functions, together with personal integrity, a positive attitude and strong work ethic.
Experience developing and using advanced Excel-based models, data analytic tools (i.e., Alteryx, Tableau) and conducting quantitative analysis.
Experience, confidence, resilience, and gravitas to work with senior leaders and able to establish rapport with key stakeholders.
Ability to quickly establish credibility with diverse audiences and be perceived as an empowering leader yet be hands-on when necessary. Consistently retains a sense of the 'bigger picture.'

Preferred:
Advanced degree (such as JD/MA/MS/MBA) or other similar certification or prior monitoring experience preferred.
Project management experience and/or certification preferred (i.e., Project Management Professional).

Personal Competencies/ Behaviors:
The ideal candidate will be solutions- and results-orientated and will display personal and professional maturity.
Proven leadership skills with an ability to set a vision, inspire, champion change, and drive innovative thinking.
Collaborative, team player that leads by example.
Strong strategic thinking skills with ability to see the big picture, and to formulate and execute strategy.
Excellent influencing, interpersonal and communication skills.
Demonstrated ability to network, engage and partner with other functions, and establish positive relationships.
Strong judgment with proven ability to identify to implement solutions.
Strong organizational and project management skills and ability to execute through others.
Proven analytical skills and sound judgment.
Practical approach to problem-solving.
Consistently demonstrate and adhere to Gilead's Core Values and create and inspire a team culture committed to the same.

Gilead Core Values Gilead Core Values

Integrity (Doing What's Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

The salary range for this position is: $154, $199, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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