
Senior Ethics and Legal Compliance Manager - ANZ
- Melbourne, VIC
- Permanent
- Full-time
- 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.
- 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.
- 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
- 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)