APAC Compliance Manager

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 accordance with the Company policy.
• Position will require travel as needed.

Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.