Senior Manager, US Compliance Monitoring

Senior Manager, US 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



Senior Manager, US 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.The Role

We are seeking a Senior Manager of US Compliance Monitoring to assist in enhancing and operating Gilead's healthcare compliance monitoring program. The location of this role will be based out of Foster City, California or Remote and will report to the Head of Compliance Monitoring-US.

Essential Duties and Job Functions

This individual will support the Head of Compliance Monitoring-US 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 leverage of data analytics, risk-based sampling, support of potential investigations and complaints, and observation at various activities & events to identify potential areas of focus. The individual will work closely with colleagues within the Global Compliance, Global Therapy Area Legal, and Legal(GTAL) organizations and across different functions, including key partners such as IT, Commercial, Development, Medical Affairs, Public Affairs, Government Affairs, Finance and Clinical, among others, in order to leverage information from relevant systems for identification and address of potential compliance-related issues. A key goal of this position is to help drive innovation and consistency in our approach to compliance-related monitoring within the Global Compliance Monitoring Team to ensure both Gilead and industry best practices are shared and adopted across functions.

Key responsibilities also include the following:

• Support the Head of Compliance Monitoring-US in partnering with colleagues across Legal, including Global Therapeutic Area Legal teams, and various business functions to develop and align on a multi-faceted monitoring strategy by using outlets such as data analytics, robotics, 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 a monitoring-focused working group, Global monitoring plan & annual risk assessment.
• Ensuring the carrying out of the US monitoring plan with special focus on areas of historic risk, data anomalies, complaints, and other priorities raised by leadership - tracking and reporting resolution as applicable.
• Support the Head of Compliance Monitoring-US to ensure timely and appropriate action is taken by partnering with business, US Compliance Execution and GTAL to address potential risks and issues identified through periodic risk assessments and compliance monitoring.
• Collaborate with the Compliance Systems and 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.
• Capture and report compliance-related metrics obtained through monitoring.
• Partner with other Legal and Compliance colleagues, and various business functions to promote a unified strategic vision that supports business activities in a way that is both operationally effective and compliant.
• 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.
• Connect other departments of Legal across the company concerning compliance-related data capture systems (e.g., Global Therapeutic Area Legal, Data Privacy, Litigation & Investigations, Intellectual Property, Legal Operations).
• 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.

Knowledge, Experience and Skills

Gilead is looking for 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 US-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.

Detailed requirements include:

• 6-8+ years of relevant prior pharmaceutical or biotechnology industry experience, including extensive professional experience advising on anti-kickback/anti-bribery laws and other compliance mandates.
• Bachelor's degree required. Advanced degree (such as JD/MA/MS/MBA) or other similar certification or prior monitoring experience preferred.
• Project management experience and/or certification preferred (e.g., Project Management Professional).
• Excellent verbal and written communication skills in English.
• 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 (e.g. 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 testing sheets that captures key controls which also aligns to the expectations of applicable policies)
• Ability to execute a monitoring activity with little to no oversight (e.g. perform data monitoring and analyze data for unusual 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 (e.g. 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 organisation with multiple functions, together with a positive attitude and strong work ethic.
• Experience developing and using advanced Excel-based models, data analytic tools (e.g., 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'

Personal Competencies/ Behaviours

The ideal candidate will be solutions- and results-orientated. S/he will display personal and professional maturity and have a strong work ethic and personal integrity.

• 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 Additional Section

• Integrity (always doing the right thing)
• Teamwork (collaborating in good faith)
• Excellence (working at a high level of commitment and capability)
• Accountability (taking personal responsibility)
• Inclusion (encouraging diversity)

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