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Position Overview

The Compliance Operations Program Manager - Asia Pacific (APAC) will have responsibility for leading and executing various components of the Global Transparency, Systems, & Compliance Operations and Global Privacy teams. The incumbent will work independently to provide regular Compliance, Privacy, and process training to employees in the APAC region and review requests regarding interactions with health care professionals and institutions. Fair market value evaluations (FMV) of health care professionals (HCP) will also be required. This role will serve as a member of the Global Privacy Office and support the conduction of privacy assessments, response to data subject access requests, and representation of the Global Privacy Office in key business initiatives and interactions. This position will report to the Director, Global Transparency & Compliance Operations, and work with Compliance leadership and functional teams (e.g., Finance, IT, etc.) throughout the organization to maintain and implement the Global Privacy Program.

Essential Duties

Including but not limited to:

• Immediately remediate and communicate data gaps and general issues, escalating as needed.
• Regularly liaise with outside and in-house counsel to determine applicability of specific regulations.
• Closely monitor trends and new regulations throughout APAC region.
• Potentially represent Company with industry associations, specifically regarding Compliance and associations’ codes of conduct.
• Potentially represent Global Privacy Office in interactions with customers, patients, and other third parties.
• Support translation of Compliance and Privacy documentation (e.g., policies, procedures) to Japanese language, when applicable
• Support and comply with the company’s Quality Management System policies and procedures.
• Identify and schedule project deliverables, milestones, and required tasks.
• Prepare status reports and modify schedules and plans, as needed.
• Develop and gain agreement with stakeholders, including Compliance leadership, on project plans and budgets.
• Focus on continuous improvement, specifically systems-related processes.
• Lead projects to implement, refine, or improve processes for the APAC Commercial and Medical Affairs teams.
• Partner with executive leadership in the APAC region as well as within the International business unit more broadly, to ensure successful communication, implementation, and change management regarding regulatory or internal process changes.
• Ensure systems and processes operate in a manner comporting with laws, regulations and industry standards that include, among other topics, state and federal anti-kickback statutes and their equivalents throughout APAC (e.g., JPMDA, JFMDA, JFTC Fair Trade Code), and related regulations and reporting practices (e.g., the Sunshine Act, industry association transparency requirements), compliance with FDA and its equivalents throughout APAC, CMS and relevant regulatory requirements, Japan Pharmaceutical and Medical Devices Act, JFMDA Japan Federation of Medical Devices Associations Code of Ethics and compliance with applicable corporate codes and policies (e.g., the Company’s Code of Conduct on Interactions with Health Care Professionals, which is based on the AdvaMed Code of Ethics on Interactions with Health Care Professionals).
• Create and maintain metrics for various levels of regulatory compliance monitoring, reporting and governance.
• Provide metrics and reporting directly as requested from senior and executive leaders, including contributing data for quarterly Compliance Committee meetings, Board of Directors meetings, etc.
• Effectively liaise with functions across the organization to conduct various monitoring and auditing activities.
• Conduct reviews of internal tracking spend data to ensure complete and accurate data.
• Work with business and the Global Privacy Office to conduct privacy assessments and documentation on data processing activities.
• Deliver privacy induction & training to the Japanese team.
• Support interactions with data subjects related to their rights under applicable data protection law.
• Independently identify trends and/or risks based upon data analysis.
• Execute evaluations of fair market value for health care professionals (HCP) and institutions, leveraging approved algorithms and systems.
• Review requests made by internal clients for commercial exhibit space, commercial and community-based sponsorships, memberships, and direct HCP interactions (e.g., consultants, speakers, etc.).
• Draft company standard letters and agreements necessary for commercial exhibit, commercial and community-based sponsorships, memberships and direct HCP interactions (e.g., consultants, speakers, etc.).
• Work with all levels of the compliance and legal team on policy decisions, procedures and issues.
• Identify potential weaknesses in the compliance program and proactively suggest improvements to address them.
• Collaborate with other departments to direct compliance and privacy issues to appropriate existing channels for investigation and resolution.
• Leveraging strong cross-functional collaboration skills, regularly engage with stakeholders and leadership to gather information, propose innovative process and system improvements, and ensure accurate tracking of transfers of value to healthcare professionals and teaching hospitals.
• Regularly train and educate other functions (e.g., Commercial, Medical Affairs, etc.) on the relevance of their daily duties to transparency and regulatory requirements and risks, including good documentation practices, expense reporting, and accurate tracking of transfers of value to healthcare professionals and healthcare institutions, while also at times, guiding users on the transparency system's upload process and designing templates to align with their data sources.
• Uphold the company’s mission and values through accountability, innovation, integrity, quality, and teamwork.

Minimum Requirements

• College/University Diploma or equivalent
• At least 5 years of direct professional experience with Healthcare Compliance, IT, or Finance, preferably with healthcare, life sciences, or laboratory company/industry.
• Experience providing guidance based on Japan regulations (e.g., JPMDA, JFMDA, JFTC Fair Trade Code) related to industry interactions with healthcare professionals.
• Native level proficiency in the Japanese language and professional working proficiency in the English language.
• Proficient in Microsoft Office programs, including but not limited to Visio, PowerPoint, Excel, Word, and Outlook.
• Adaptable, open to change, and able to work in ambiguous situations and respond to new information and unexpected circumstances.
• Strong written, verbal, and presentational communication skills.
• Strong analytical skills and attention to detail.
• Ability to balance multiple projects and complex tasks, while working independently, and utilizing prioritization to work towards the achievement of projects.
• Ability to function productively within a fast-paced, multi-tasking, entrepreneurial environment.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Ability to work on a designated schedule.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability and means to travel between local Exact Sciences locations.
• Work at least 60% of each week in the Exact Sciences Tokyo office.
• Ability to travel up to 10% of working time away from work location, may include overnight/weekend travel, including to Switzerland, the United States, and countries within the APAC region.
  

Preferred Requirements

• Working proficiency in other languages applicable to the APAC region (e.g., Mandarin Chinese, Korean) or in German, French, or Spanish is a plus.

Employment Term: This role includes a 3-month probationary period during which employment conditions remain unchanged. Employment is on an indefinite-term contract, and a one-month notice period is required for voluntary resignation, in accordance with company policy. Employees may be required to work overtime based on business needs, including occasional holiday and weekend work, with compensation provided per company policy and local labor regulation.

Salary Range:

The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. Additionally, this role includes either 30 hours of overtime per month or 10 hours of midnight work per month, depending on the position. This position is also eligible for a bonus.

Employee Benefits: Exact Sciences is committed to providing a comprehensive employee experience that supports well-being and professional growth through our benefits. Learn more about our benefits by selecting the country you're interested in to view specific offerings. Based on business needs and role eligibility, relocation support may also be available in accordance with company policy.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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