Sr Associate Compliance
Amgen · Thousand Oaks, CA · 1 wk ago
HybridOTHR$137k/yrFull-time
About the role
Partner with US Compliance Leads in implementing and overseeing Amgen's Corporate Compliance programs and policies, ensuring alignment across therapeutic areas and business functions.
Responsibilities
- Implement and drive understanding of Compliance and Business strategy within the business by providing actionable advice and aligning compliance initiatives with Amgen priorities
- Serve as an adviser to staff and managers, offering guidance on the interpretation and implementation of Amgen policies and procedures
- Ensure consistent adherence to applicable laws, regulatory standards, and internal procedures that impact Amgen's compliance program
- Design, develop and deliver training programs, educational materials, and workshops aligned with Amgen procedures and policies and deliver to appropriate audiences
- Lead and support compliance risk assessment and compliance management activities to identify areas of improvement opportunities and mitigating risk
- Drive continuous improvement initiatives across Compliance operations by evaluating Compliance processes, recommending enhancements, and fostering a culture of excellence and accountability
- Initiate and propose targeted improvement actions based on data-driven analysis, stakeholder feedback, and cross-functional collaboration
- Track and report improvement actions by analyzing key performance indicators and business data
- Develop compliance metrics and trend analyses to inform strategic decision-making and report to key Amgen stakeholders
- May telecommute
Requirements
Master's degree (or foreign degree) in Law, Business Administration, or related field and completion of a university-level course, research project, internship, thesis, or one year of experience in the following:
- Interpreting and implementing Office of Inspector General (OIG) Compliance Program Guidance or the IFPMA (International Federation of Pharmaceutical Manufacturers & Associations) for Pharmaceutical Manufacturers
- Interpreting and applying U.S. healthcare compliance laws and regulations, including the Federal Anti-Kickback Statute, Sunshine Act (Open Payments), and U.S. Food and Drug Administration (FDA) promotional compliance standards
- Biotechnology pharmaceutical industry including clinical trials, commercial operations, and medical operations
- Conducting or supporting risk assessments, monitoring activities, or internal audits within the pharmaceutical, biotechnology, or healthcare industry
- Compliance-related data analysis, including use of pivot tables, VLOOKUP, conditional formatting, and basic charting
- Compliance management systems including EthicsPoint for intake, tracking, and resolution of compliance matters
- Developing and delivering healthcare compliance training programs tailored to commercial, medical, or cross-functional business audiences based on global and U.S. regulatory requirements
Pay
The annual salary range for this position in the U.S. is $136,739.00 per year. This position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus.