Amgen Regional Monitoring Lead in Shanghai, China
*Manage the implementation and operation of Amgen's risk-based Healthcare Compliance (HCC) monitoring program in a designated region, including transactional and live monitoring programs.
*Maintain an in-depth knowledge of business and compliance risks in conjunction with Amgen's business plans & priorities.
- Provide in-country monitors with advice and guidance.
*Work with peers to ensure that monitoring is conducted consistently across all OUS regions.
*Actively participate in strategic and transformational projects to enhance monitoring at Amgen.
*Participate in ABAC & Global Risk Assessment processes.
*Represents region and supports Global Risk Assessment that serves as key input to Global Monitoring planning
*Translates and tailors Global Monitoring plan into a regional monitoring plan leveraging local/regional knowledge risks and input from local compliance and other stakeholders
*Executes/coordinates live, data & transactional monitoring across the region (including managing in-country monitors where appropriate) to achieve overall program objectives
*Engages and manages third parties to conduct and complete regional monitoring plan
*Presents the results of monitoring with senior leaders at local/regional level including advising on and tracking completion of improvement actions
*Provides insightful analysis and understanding of monitoring trends for stakeholder reporting and follow up
*Maintains keen aware of business plans/objective, regional risks (internal/external), and industry-related trends
*Develops/maintains strong relationships with peers and the OUS Monitoring Lead for calibration and consistency of monitoring globally
*Ensuring that findings are documented and reported and that improvement actions are closed out.
*Escalates findings to Investigations team as appropriate for further review and follow up
*In-depth knowledge and practical experience of compliance matters in the Life Sciences/Pharmaceutical sector
*Detailed knowledge of international business ethics, healthcare compliance, privacy, anti-bribery/anti-corruption, and compliance monitoring
*Employs project management skills to ensure multiple objectives are met and to proactively plan for the future
*Innovative approach to developing novel, problem-solving strategies based on project objectives and business priorities
*Capability to operate independently and be guided by the monitoring team's plans
*Capacity to identify and integrate trends and data into plans, reporting, improvements, and recommendations
*Ability to maintain strong relationships with senior leaders in order to identify their requirements and potential opportunities for improvement
*Strong leadership skills Excellent written and spoken communication
*Doctorate degree & 4 years directly related experience OR
*Master's degree & 8 years of directly related experience OR
*Bachelor's degree & 10 years of directly related experience OR
*Associate's degree & 12 years of directly related experience OR
*High school diploma / GED & 14 years of directly related experience
*Over 6 years of experience in business operations, program management and compliance and control related functions.
*Experience as monitoring, auditor, or other control related function in the JAPAC region a plus.
*Ability to work both independently and as part of a team to resolve complex matters in a responsive way.
*Excellent drafting, writing and oral communication in both Chinese and English, strong analytical, organizational, and strategic thinking skills.
*Other Asian languages a plus.
*Ability to work effectively in a global environment.
*Ability to well manage work under a matrix organization structure and comparably complicated environment.
*Demonstrated ability to work independently, deliver against critical business objectives, implement complex instructions, prioritize, be proactive, resolve conflicts, meet deadlines, follow through on assignments, and be a team player with multiple cultures, geographies and languages
*Experience with an emphasis on regulatory, financial legal, or healthcare compliance processes and requirements
*Knowledge of the global healthcare industry and the laws and regulations relating to the development, approval, and commercialization of biotechnology/pharmaceutical products
*Ability to travel is preferred.