|部署・役職名||ビジネス・コンプライアンス・リード（専門管理職） / Japan Business Compliance Lead|
The BU Compliance Lead is responsible for overseeing Business Partnersʼ compliance
strategy, establishing strong compliance culture in each department, guiding to strategic
direction for related laws, regulations, and corporate policies/procedures and
collaborating with Global BU Compliance team. The Business Compliance Lead acts in the
capacity of professional risk assessment and compliance consultants for the Business
Business Compliance Lead has a role ＆ responsibilities to realize the following in－market compliance
1. Compliance Governance ＆ Organization
• Take a lead role in supporting compliance organization as needed through the CLT, CCC, or other
• Report senior leaders on compliance status in Japan on a regular basis.
• Provide advice and strategic direction to Business Partners on compliance related matters.
• Liaise with Global/Regional Compliance to ensure consistency when needed and that local
regulations are adhered to.
• Manage compliance violations or matters.
• Support/lead new compliance initiatives/projects requested from Country Compliance Lead.
• Support compliance activities in each workplace through Compliance Champions.
• Promote a culture of Compliance as a direct link to protecting patients and therefore public trust
• Advise Compliance initiative owners for local policies and procedures establishment/revision.
• Draft and publish internal compliance standards/guides.
• Communicate and educate internal compliance standards/guides to colleagues.
• Analyze impact on new/reviewed laws, regulations, local policies and procedures.
• Supervise communicating and education healthcare laws, regulations to colleagues.
• Implement any new global standards ensuring they also are in compliance with Japanese laws
Japan Business Compliance Lead
• Support identifying areas where monitoring/audit can help to improve compliance program.
• Support monitoring of compliance mindsets in Japan, workflow and transactions.
• Oversight corporate Audit.
• Help translate monitoring results into meaningful action with Business Partnersʼ support.
• Deliver trainings to new joiners, staff and Line Manager.
• Deliver trainings to Business Partners in charge.
6. Risk Assessment ＆ Mitigation
• Manage/attend risk assessment committee for compliance issues.
• Assess risk and provide advice for compliance issues.
7. Response ＆ Corrective Actions
• Provide advice on compliance matters and examinations （e.g. MAPP, FCPA, GCO Speaker list）.
• Analyze root causes and plan CAPAs for monitoring/audit findings and compliance violations.
• Liaise with JPMA for code issues from other companies.
8. 3rd Party Compliance
• Monitor co－promotion relationships to mitigate enforcement risks.
• Advise the business on proper interactions with 3rd parties.
9. M＆A Compliance
• Support business transactions such as M＆A, co－promotes, or any contracts with 3rd parties and
mitigating any risks.
10. Compliance Japan Management
• Develop Compliance Japan vision, strategy and annual plan.
• Ensure Compliance Japan budget.
• Develop talent ＆ motivate members in Compliance Japan by cultivating compliance mindset and
skills to manage compliance matters and culture.
11. External Affairs
• Approach MHLW, JPMA and other external organization （e.g. PhRMA, Pharma Legal Affairs ＆
etc.） to enhance and shape compliance environment in the pharmaceutical industry.
• Work with other pharma companies to raise the bar of compliance across the industry in Japan.
【歓迎（WANT）】Qualifications （i.e., preferred education, experience, attributes）
• University degree in Law/ Finance with strong academic background, Masterʼs Degree preferred.
• 8 － 12 Years of professional experience in Legal, Business Operations, Consulting, Audit, Program
management and / or Compliance and control related functions.
• Comprehensive understanding of the local regulatory environment （as it related to Compliance）,
relevant international and local Codes of Practice, guidelines, regulations as well as applicable
policies and procedures （only for internal candidates）
• Understanding of US FCPA and pharmaceutical industry experience is preferred
• Strong commitment to Ethics ＆ Values including Integrity, Trust, Alignment ＆ Compliance
• Strategic and Innovative Thinking
• Strong Work Ethic
• Strong Business Acumen and ability to work with senior leaders
• Strong Decision Making capabilities
• Strong Communication skills, verbally and otherwise
• Ability to effectively analyze issues and provide relevant advice
• Commits to teamwork within the country compliance organization
• Effectively works with business in a partnership mindset
• Works with client collaboratively to find a realistic and reasonable solution, that considers both
the business needs along with risk assessment
• Experience and proven capabilities in compliance and/or audit matters
• Ability to work both independently and as part of a team to resolve complex matters
• Demonstrated leadership and collaboration skills
• Excellent writing and oral communication in both English and Japanese
• Strong analytical, organizational, and strategic thinking skills
• Ability to work effectively in a global environment
• English and Japanese fluency strongly preferred （TOEIC: 730 or above）