APAC Compliance Manager

Job Title APAC Compliance Manager Requisition JR000015940 APAC Compliance Manager (Open) Location Tokyo, Japan Additional Locations Job Description Summary The Asia-Pacific (APAC) Compliance Manager will report to Keenova’s Head of Compliance Operations and International Business, with a dotted line to the General Manager, Keenova Pharma KK Japan and will provide subject matter expertise and support for Keenova’s Compliance Program in the APAC region with focus on the Japan and Australia markets and distributor relationships in the region. This role is an important member of the global Corporate Compliance team and supports global initiatives to reinforce Keenova’s Integrity culture. Responsibilities include day-to-day business advisement, Health Care Professional engagement process and approvals, APAC compliance-related policies and procedures, conducting training for Japan and Australia teams as well as distributors in the APAC region, supporting internal investigations and bringing general compliance awareness and Integrity culture to the business. The Compliance Manager will be asked to work with various cross-functional teams including commercial, medical, legal, regulatory, internal audit, and third-party advisors to identify business risks and implement controls. Job Description Essential Functions General activities 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 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 As needed, 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 Compliance Policies, Procedures & Training 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. Manage Ethics Hotline Reports and Investigations In coordination with Investigations team, 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 In coordination with Human Resources, manage corrective action implementation for Compliance-related matters by providing verbal and written coaching to employees for policy violations Manage Annual Healthcare Compliance Risk Assessment and Mitigation Activities 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 In collaboration with global Corporate Compliance team, develop the APAC region’s risk mitigation plan, including audit and monitoring plan with Corporate Compliance colleagues Align with global Corporate Compliance and 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 Qualifications Education / Experience / Skills: 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 Organizational Relationship/Scope Reports to Head of Compliance Operations and International Business with dotted line to the General Manager, Keenova Pharma Japan. Frequent communication and interaction with global Corporate Compliance. Working Conditions A hybrid work structure where employees can work remotely and from the office, in