Job Purpose

The Ethics & Compliance Officer Japan & South Korea 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 CSL Behring in Japan and CSL Behring and CSL Seqirus in South Korea. The incumbent is also responsible for executing programs, strategies, priorities and operations as established by the Regional Ethics & Compliance (E&C) Director for APAC. The role is responsible for establishing short term to medium strategies to ensure that the Japan & South Korea businesses are risk aware, compliant and change ready across all business functions including ComOps, R&D, Operations and all other Enabling functions in the Japan & South Korea region.

The incumbent in this role is a key advisor in Ethics & Compliance in Japan & South Korea 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 Japan ethics and compliance knowledge (and similar knowledge in South Korea, or willingness and ability to acquire the 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 APAC Regional Ethics & Compliance Director, and then recommend them for action.

The Ethics & Compliance Officer Japan & South Korea will report to the APAC Regional Ethics & Compliance Director, ensure that the Japan & South Korea 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 Japan & South Korea is responsible for setting and 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 Behring and CSL Seqirus in Japan & South Korea, 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 & Compliance Officer APAC. The role is responsible for establishing short term to medium strategies to ensure that the Japan & South Korea region is risk aware, compliant and change ready across all business functions including ComOps, R&D, and all other Enabling functions across the CSL Behring and CSL Seqirus businesses in the Japan & South Korea region.
2. Acts as the key ethics and compliance business partner and compliance advisor for the Japan & South Korea business leadership and employees in customer facing functions, such as Sales, Medical, Marketing and Market Access, recognized as the subject matter expert (SME) in compliance. As compliance SME the incumbent is responsible for advising on topics such as new business opportunities, continuous risk assessment, interactions with external stakeholders, gifts & entertainment, donations, charitable contributions, speaker engagements, fair market value, interactions with government officials, compliance with anti-corruption laws, etc. as well as undertaking compliance risk assessments including directing the maintenance of obligations to controls mapping for CSL Behring and CSL Seqirus in Japan & South Korea 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 Japan & South Korea.
3. Responsible for managing, leading and organizing the Japan & South Korea Compliance Committee meetings at least on a quarterly basis. Maintain records of the meetings and ensure the Japan Compliance Committee Charter is up-to-date.
4. Assists the Japan Business in managing the effort to generate high quality, accurate and consistent data for the filings and reports related to payments and transfer of value to Health Consumer Organisation (HCO) and Healthcare Professionals (HCP) for the purpose of Japan's transparency reporting.
5. Lead and assure effectiveness of third party due diligence, on-boarding and compliance program. Provide targeted compliance training as needed and support the Japan & South Korea businesses with risk management processes, third party reviews and annual compliance certification processes.
6. Promote and contribute to a values-based compliance culture of the Japan & South Korea businesses, including ensuring productive and collaborative relationships with Japan Legal Counsel and/or APAC Legal Services and Operations function.
7. Participate at Executive Committee meetings by providing compliance advice and insights to the senior leaders. On an annual or ad-hoc basis, to participate and/or conduct Business Integrity workshops at Business' annual meetings and other business forums (e.g. sales cycle meeting, Brand Team, Medical, etc).
8. Responsible for implementation of internal and external compliance standards to business practices, programs, and processes in Japan & South Korea. Provides ongoing compliance risk advice and guidance to all business operations in Japan & South Korea 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 to CSL Behring and CSL Seqirus Japan & South Korea.
9. Develops and implements plans to ensure implementation of local CSL Behring and CSL Seqirus 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 Group's Ethics & Compliance requirements.
10. Manages the execution and delivery of Japan & South Korea 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 for CSL Behring and CSL Seqirus in Japan & South Korea, liaise with Legal Operations and Services to develop training communications and materials for impacted stakeholders, and ensure adequate visibility of compliance program initiatives.
11. Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct in Japan & South Korea by evaluating or recommending the initiation of investigative procedures. Ensures the process for handling of such violations is in accordance with the global investigation handbook. Includes support to compliance investigations (including Global Speak Up Hotline investigations).
12. Leads implementation of strategic compliance risk management and oversee management of compliance risk management meetings for CSL Behring and CSL Seqirus in the Japan & South Korea region by staying current on development and treatment action plans for top compliance risks for the CSL Group Japan & South Korea and identifying potential areas of compliance vulnerability and risk. 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.
13. Responsible for effective third-party due diligence and onboarding processes for Japan & South Korea as part of the broader Third-Party Risk Management technology and process. Supports the EREC Monitoring and 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.
14. Collaborates closely with the EREC Monitoring and Assurance team to support the development of and then periodically review the Japan & South Korea compliance risk based monitoring program, including audit plans and cadence. Includes providing compliance SME input into and supporting the EREC Monitoring and Assurance team with implementing a routine-controls testing program.
15. Responsible for timely, relevant, focused, and actionable reporting in conjunction with the EREC Monitoring and Assurance team to ensure an active and robust Company compliance program, including oversight and monitoring of program effectiveness.
16. Monitors regulatory activity and legislation in Japan & South Korea 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 Group's Ethics & Compliance requirements in conjunction with the APAC Regional Ethics & Compliance Director.
17. Proactively engages and partners with E&C, EREC, Legal and Business colleagues.
18. Collaborates on and manages responsibilities & projects assigned by the APAC Regional Ethics & Compliance Director that may be global in nature or region specific.

Reports To:

APAC Regional Ethics & Compliance Director

Direct Reports:

N/A

Job Specifications

• Bachelor's degree in Business, Risk Management or Law; advanced degree preferred
• 10+ years of progressive experience in compliance risk management.
• Demonstrable compliance experience, ideally in a multinational company; pharmaceutical, life sciences or manufacturing background preferred.
• Strong understanding of local regulations and industry guidance (including Kekkyo Code, JPMA Code of Practice, EFPIA, Japan Fair Trade Council, Ministry of Health Labour and Welfare's Guidelines on Sales Information Provision Activities on Ethical Drugs) related to the pharmaceutical industry and their political influences.
• Practical experience of implementing compliance projects
• Fluency in Japanese and 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 ethics and compliance 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
• Strong negotiations skills
• 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
• Cultivates talent and takes proactive steps to secure future talent
• 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.
• Cultivates talent and creates development opportunities.

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