Legal & Compliance Manager

1. Compliance
- Organize Compliance training, awareness session, bilateral communication with keeping high compliance literacy for employees following headquarters' Compliance program, effective local program and followed by local regulation and law. These activities include annual training (e.g. Psychological Safety training...) , e-learning, and workshops per Eisai's Compliance Handbook.
- Operate Compliance Counter function (Consultation, Report, Countermeasure and including investigation based on making clear process), ensuring confidentiality and non-retaliation for whistleblower reports
- Monitor local events from event Compliance perspective due to mitigate potential risk based on local/ regional regulation and law, including events that having interactions with Healthcare Professionals (HCPs) and Healthcare Organizations (HCOs) to ensure transparency and compliance
- Report to Compliance department at Headquarter (including assessment, activity report, whistle blowing report) and resolve the matter as early as possible, establishing clear and specific timelines for handling these reports to avoid delays or prolonging processing, ensuring confidentiality and non-retaliation for reporters, in line with Eisai's non-retaliation and confidentiality policies.
- Participation in Regional Compliance meetings is required, to share best practices, discuss compliance issues, and ensure alignment with Eisai's global and regional initiatives.
- Risk Management (regional and local as CSA Promotor), including risk assessments, risk mapping, and follow-up on critical risks, implementing internal controls to prevent fraud, conflicts of interest, and corrupt practices, in accordance with Eisai's Internal Control Policy and Anti-Corruption Policy.
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2. Legal with compliance perspective
- Review and give comments on related to standard business contracts, agreements, arrangements, and legal documentations to secure the compliance of current regulations and to protect the Company's interests by advising on a wide range of legal issues, including corporate and commercial matters, competition law, corporate governance, employment law, intellectual property and technology law, digital product license terms and conditions, data protection and privacy law, biotech law, tax law, risk and contract management, and dispute resolution, ensuring fair market value for engagements with Healthcare Professionals (HCPs) and Healthcare Organizations (HCOs), and preventing improper payments or inducements.
- Give timely and appropriate legal related to Compliance perspective advice for internal clients on various business operation matters, emphasizing ethical standards of integrity, respect, and openness, including guidance on promotional activities, clinical trials, and regulatory interactions aligned with Eisai's Charter of Business Conduct and global standards
- Respond to legal disputes, litigations or Compliance issues, including timely communications with headquarter in Japan and with external counsels, while leading internal investigations into compliance violations to ensure prompt corrective actions and prevention of recurrence.
- Enhance and maintain the corporate governance, ensuring adherence to antitrust, labor, and pharmaceutical regulations, including implementation of internal controls, management of conflicts of interest, and periodic assessments aligned with Eisai's Global Internal Control Policy.
- Review and approve marketing and promotional materials to ensure compliance with pharmaceutical advertising regulations, prohibiting off-label promotion and providing accurate, balanced scientific information, aligned with Eisai's Code of Practice and industry standards
- Handle corporate housekeeping matters based on the Companies Act (e.g., support General Director to hold general meetings of shareholders and board meetings, create minutes, amend the company's articles of incorporation, register changes, etc.)
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3. Learn and Development
- Offer continuous support and companionship to team members across various departments within the company, including personalized mentoring on career development and practical application of compliance principles in daily operations.
- Lead orientation and onboarding initiatives for new hires, ensuring they integrate seamlessly into their roles and teams, including introductions to compliance culture, Eisai's Code of Practice, and global ethics policies.
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