Job Description

Job Purpose

• The Ethics & Compliance Officer ANZ is responsible for implementing strategic goals, planning efforts, managing projects and providing measurable inputs into processes, standards and operational plans for the Ethics & Compliance function for all CSL Group entities in ANZ including CSL Behring, CSL Seqirus and CSL Vifor (“CSL Business Units”). The incumbent is also responsible for executing programs, strategies, priorities and operations as established by the Regional Ethics and Compliance (E&C) Officer APAC. The role is responsible for establishing short term to medium term strategies to ensure that the ANZ is risk aware, compliant and change ready across all business functions including Commercial, Clinical (R&D), Operations and all other Enabling functions across CSL Behring, CSL Seqirus and CSL Vifor businesses in ANZ.

• The incumbent in this role is a key advisor in Ethics & Compliance and will partner with and support the business stakeholders in ongoing compliance risk identification, management, controls and mitigations. The incumbent will have detailed and up to date ethics & compliance knowledge in order to implement and maintain routines and ongoing cadence to manage, monitor and analyse regulatory/enforcement and business changes as well as suggest ‘best practices’ in the industry to the Regional Ethics and Compliance Officer APAC, and then recommend them for action.

• The Ethics & Compliance Officer will report to the Regional Ethics and Compliance Officer APAC, ensure that the ANZ CSL Business Units E&C Program direction is both consistent with and supportive of CSL Global Ethics & Compliance Program standards, actively contribute to developing a Company culture of compliance and support the business through client counselling, training/ communications, auditing and monitoring, Speak Up hotline report review, investigation and remediation. 

RESPONSIBILITIES AND ACCOUNTABILITIES

1. The Ethics & Compliance Officer is responsible for implementing strategic goals, planning efforts (budgets, operational plans etc.), managing projects and providing measurable inputs into processes, standards and operational plans for the Ethics & Compliance function for CSL Business Units in ANZ in collaboration and consistent with APAC Regional and Global E&C leadership. The incumbent is also responsible for executing programs, strategies, priorities and operations as established by Regional Ethics and Compliance Officer APAC. The role is responsible for establishing short term to medium strategies to ensure that the ANZ is risk aware, compliant and change ready across all business functions including Commercial, Clinical (R&D), Operations and all other Enabling functions.

2. Acts as the key ethics & compliance business partner and compliance advisor, providing counsel, specialist input and expertise to CSL Business Units in ANZ, recognized as the subject matter expert (SME) in compliance. As compliance SME the incumbent is responsible for compliance risk assessments including directing the maintenance of obligations to controls mapping and supporting the business in developing controls to mitigate issues through the issues/risks management process. Also ensures and implements compliance risk assessment cadence for all business operations and functions in ANZ.

3. Responsible for implementation of internal and external compliance standards to business practices, programs, and processes in ANZ. Provides ongoing compliance risk advice and guidance to all business operations regarding application of internal and external (code, regulatory, legal, other) standards to business practices and programs and impacts from regulatory and business changes. Ensures consistent oversight and E&C standards.

4. Develops and implements plans to ensure implementation of local policy and internal obligations in accordance with global/ APAC region direction or changes in local regulations, business conditions or from events that may impact the CSL Business Units Ethics & Compliance requirements.

5. Manages the execution and delivery of compliance training programs and works with business units and functions to implement. The incumbent will not only identify requirements and provide inputs to training materials with compliance subject matter expertise, but support development of Ethics & Compliance content for compliance training programs, liaise with Legal Operations and Services to develop training communications and materials for impacted stakeholders, and ensure adequate visibility of compliance program initiatives.

6. Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating the need to initiate an investigation and lead and investigation in accordance with the global investigation playbook.

7. Leads implementation of strategic compliance risk management and co-chairs with the leadership of CSL Business Units in ANZ the quarterly compliance committees by staying current on development and treatment action plans for top compliance risks and identifying potential areas of improvement to further enhance compliance program (including but not limited to developing policies, trainings, communications, business advice, supporting monitoring initiatives, etc.). The incumbent will support the business to develop/implement corrective action plans for resolution of problematic issues and provides general guidance on how to avoid or deal with similar situations in the future.

8. Responsible for effective third-party onboarding and due diligence processes as part of the broader Third-Party Risk Management process. Supports the EREC Monitoring & Assurance team in providing SME input to develop the select monitoring program for third party risk assessments. Provides/ enables targeted ethics & compliance training as needed and support business with compliance risk management processes, distributor/ 3rd party reviews and annual compliance certifications as needed.

9. Collaborates closely with the EREC Monitoring & Assurance team to support the development of and then periodically review compliance risk based monitoring program, including audit plans and cadence. Includes providing compliance SME input into and supporting the EREC Monitoring & Assurance team with implementing a routine-controls testing program.

10. Responsible for timely, relevant, focused, and actionable reporting in conjunction with the EREC Monitoring & Assurance team to ensure an active and robust Company compliance program, including oversight and monitoring of program effectiveness.

Monitors regulatory activity and legislation as well as enforcement, environment, trade and business news, competitor activity and industry trends and related information/materials to proactively anticipate, or swiftly react to changes in business conditions or events that may impact the CSL Business Units’ Ethics & Compliance requirements in conjunction with the Regional Ethics and Compliance Officer APAC.Proactively engages and partners with E&C, EREC, Legal and Business colleagues.

REPORTING RELATIONSHIP

Reports To: Regional Ethics and Compliance Officer APAC

JOB SPECIFICATIONS

Education

• Bachelor’s degree in Business, Risk Management or Law; advanced degree preferred

Experience

• 10+ years of progressive experience in compliance risk management.

• Demonstrable compliance experience, ideally in a multinational company; pharmaceutical, life sciences or manufacturing background preferred.

• Knowledge of pharmaceutical/ healthcare law, regulations, and codes of conduct

• Practical experience of implementing compliance projects

• Fluency in English (both in oral and written communication)

• Excellent written and spoken communication skills, including strong presentation skills

• Strong stakeholder management and interpersonal skills

Competencies

• Expertise as to healthcare and/or pharma laws, regulations, standards, codes of conduct impacting compliance program requirements

• Healthcare or pharma compliance program regional standards

• Strong analytical skills with the ability to develop and apply pragmatic solutions to complex compliance / E&C matters

• Self-motivated, self-starter, results oriented

• Commitment to being part of a global team, including required meetings at nontraditional work hours

• Ability to work in a cross-functional, cross-cultural matrixed environment

• Thinks beyond and incorporates external factors into business strategy

• Unleashes outcomes and creates an environment of decision making and appropriate risk taking

• Ignites agility and creates a nimble environment

• Inspires the future and drives the strategy throughout the organization

• Excellent networking skills and ability to influence others to accept practices and approaches, and ability to communicate and influence executive leadership.

• Inspires the future and ensures teams buy into the strategy.

• Strong negotiating and drafting skills.

• Strong business acumen and judgment.

• Strong communication and stakeholder influencing skills.

• Builds bridges and empowers One-CSL teams.

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.