Senior Ethics and Legal Compliance Manager

Senior Ethics and Legal Compliance Manager - ANZ

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Overview

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.

Gilead Sciences Pty Ltd 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.

We are seeking a Senior Manager Compliance to assist in enhancing and operating Gilead's healthcare compliance monitoring, risk assessment, and third-party due diligence programs for the Australia and New Zealand business (Gilead ANZ). The location of this role will be based in Melbourne, Australia.

The role reports to the Head of Legal and Compliance and is part of a Legal and Compliance team.

Gilead is currently changing the way its approach to healthcare compliance, and this role provides an opportunity to shape the future for Gilead ANZ.

Essential Duties And Job Functions

This individual will support the monitoring, risk assessment, and third-party due diligence teams with activities in compliance with relevant laws, the Medicines Australia Code of Conduct, and as Gilead's Healthcare Compliance Policies and Processes. These activities will include leveraging data analytics, risk-based sampling, leading risk assessment in healthcare compliance, training and discussions, and supporting any investigations and complaints.

The individual will work closely with colleagues 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 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, risk assessment, and due diligence to ensure both Gilead and industry best practices are shared and adopted across functions.

Key Responsibilities Include The Following:

• Support the team to develop and align on a multi-faceted healthcare compliance monitoring and risk assessment strategy.
• Drive the timely development and propagation of ongoing enhancements to the company's healthcare compliance monitoring and risk assessment program. Including
• Collaborate with the team to ensure timely and appropriate action is taken to address potential risks and identified issues.
• Partner with various business functions to explore ways in which monitoring and risk assessment related data may be used to support business strategy and objectives in a compliant manner.
• Support various business functions in designing business-led monitoring approaches of both higher risk activities and third parties.
• Responsible for review and approval of activities and engagements in defined areas of the business, including membership of the local grants committee.
• Development and deployment of healthcare compliance training associated with Gilead's healthcare compliance policies.
• Day to day management of compliance and governance committees.
• Responsible for facilitating requests for diligence on new and existing vendors, including communicating with internal colleagues and third parties to gather all required information to complete diligence.
• Conducting review of due diligence questionnaires and external checks to identify potential red flags or areas for further inquiry.
• Serving as a resource and point-of-contact for questions from internal colleagues and third-party representatives going through due diligence.
• Compiling and analysing reports and metrics and presenting results to colleagues, so that we can continually assess and adjust our risk-based program.
• Manage data flow from data sources to end reporting engine for transparency reporting of transfers of value to healthcare practitioners and other key stakeholders, including taking corrective actions and remediation of data to ensure that correct, complete and accurate data flow into the Gilead's global transparency systems.
• 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 compliance 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 and has relevant experience with the Australian healthcare compliance laws and codes. The candidate must have a strong background and exposure to healthcare compliance-related monitoring and risk assessment, compliance-related systems, with experience in change management to support effective enhancement of Gilead operations.

Education And Skills

• 7+ years of relevant prior pharmaceutical or biotechnology industry experience or other experience in highly regulated industries, including extensive professional experience advising compliance issues compliance mandates.
• Bachelor's degree required. Advanced degree or other similar certification preferred. Legal qualifications and legal practicing certificate are not required but may be favourable.
• Project management experience certification preferred.
• 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.
• Excellent interpersonal and influencing skills, an inquisitive mind, and the ability to work effectively in a global, matrixed organization with multiple functions, together with a positive attitude and strong work ethic.
• Ability to present complex information in an accurate and persuasive manner to all levels of management.
• Experience, confidence, resilience, and ability to establish rapport with key stakeholders.
• Experience developing and using advanced Excel-based models, data analytic tools (e.g., Alteryx, Tableau) and conducting quantitative analysis including using AI tools.
• Experience with conducting healthcare compliance monitoring, risk assessments and third-party due diligence.
• Ability to plan monitoring activities with little to no oversight. This would include:
  • creating a project plan that clearly identifies the objective, scope, and monitoring approach;
  • generating interview guides that helps facilitate discussions to better understand the risk associated with processes; and
  • creating 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. This would include:
  • performing data monitoring and analysing data for unusual trends, outliers, and compliance with applicable policies;
  • performing live monitoring to identify compliance issues through in-person or virtual review of an activity;
  • performing process monitoring to identify compliance issues through documentation review of an activity; and
  • sharing and validating preliminary observations with the business.
• Ability to report on a monitoring activity with little to no oversight. This would include creating monitoring reports that clearly documents the objective, approach, observations, recommendations, and clearly present the objective, approach, and results of the monitoring report.

Competencies and Behaviours

The ideal candidate will be solutions and results orientated. They 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

• 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)

For Current Gilead Employees And Contractors

Please apply via the Internal Career Opportunities portal in Workday.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Legal

Industries

• Pharmaceutical Manufacturing

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