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About the Role

The Asia-Pacific (APAC) Compliance Manager will provide subject matter expertise and support for Keenova’s Compliance Program in the APAC region, focusing on Japan and Australia markets and distributor relationships. This role is an important member of the global Corporate Compliance team, supporting global initiatives to reinforce Keenova’s Integrity culture.

Responsibilities

Review and approve HCP engagement activities and conference sponsorships
Develop regular reports for compliance and business leadership
Attend global Corporate Compliance team staff meetings and calls as required
Maintain/enhance knowledge of APAC region industry trends, changes in laws and government guidance and actions to identify areas for enhanced monitoring effectiveness
Conduct quarterly calls with Japan and Australia General Managers
Conduct third party due diligence on third party intermediaries in accordance with the global Anti-Bribery and Anti-corruption process
Execute Medical Compliance Review for Commercial and Medical
Provide guidance to Medical including information provision activities by MRs and MSLs
Provide Compliance review for promotional and medical materials including presentation decks from HCP speakers for company sponsored events
Provide reports to the Review and Supervisory Committee with the third party who provides the necessary advice to the supervisory division for external monitoring requirements
Review, recommend and implement improvements to APAC region policies, procedures and Frequently Asked Questions (FAQs)
Provide guidance to the field on questions received about policies and procedures
Develop the annual training requirements for the APAC region in conjunction with the global Corporate Compliance team
Manage and oversee the Compliance Training and Communications Plan for the APAC region in coordination with global Corporate Compliance team
Conduct live trainings, including new hire training, pre-conference guidance, APAC distributor training including Anti-Bribery, Anti-Corruption and Healthcare Compliance
Assist in developing and reviewing translations of speak up materials, policies and procedures or training materials applicable for the APAC region
Assist with APAC region Healthcare Compliance (HCC) investigations, including scripting interview guides, interviewing employees, writing investigation reports, reviewing findings with leadership where necessary, and conducting additional training to employees
Collaborate with Compliance internal investigations and risk mitigation team members and other functions to leverage auditing and monitoring activities for Ethics Hotline reports
Manage corrective action implementation for Compliance-related matters by providing verbal and written coaching to employees for policy violations
Coordinate the APAC region’s compliance risk assessment, working with the global Corporate Compliance team, which will include obtaining annual business plans, completing the surveys and participating in meetings to discuss results and mitigation plan
Develop the APAC region’s risk mitigation plan, including audit and monitoring plan with Corporate Compliance colleagues
Perform the auditing and monitoring activities on the annual plan for the APAC region, including monitoring speaking engagements, field rides with Sales Representatives and records review of promotional activities
Report progress on auditing and monitoring activities to the global Corporate Compliance team on a quarterly basis
Partner and collaborate with business partners to enhance business processes based on monitoring results to effectively integrate compliance into daily business operations

Requirements

Bachelor’s degree required
5 years minimum industry experience
2 years compliance or related experience
In-depth knowledge of the industry’s standards and regulations related to compliance with healthcare laws
Able to work independently and know when to appropriately escalate an issue for resolution
Capacity of problem solving - anticipating, initiating and resolving issues
Demonstrated ability to communicate effectively with individuals up, down, and across the organization
Excellent technical and communication skills
Fluent in Japanese and English

Skills

Compliance
Healthcare Compliance
Anti-Bribery
Anti-Corruption
Risk Assessment
Auditing
Monitoring
Training
Investigations
Policy Development
Communication
Problem Solving

Location

Tokyo, Japan

Work Type

Hybrid
Travel as needed

Experience Level

5 years minimum industry experience
2 years compliance or related experience

Education Level

Bachelor’s degree

Benefits

Competitive pay
Total Rewards package

About the Company

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.
We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology.
We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.
We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.