Sr Associate Compliance Job Thousand Oaks area,California USA,Business

Career Category

Compliance

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Associate Compl iance

Duties: Partner with US Compliance Leads in implementing and overseeing Amgen’s Corporate Compliance programs and policies, ensuring alignment across therapeutic areas and business functions;
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; and 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 Ethics Point for intake, tracking, and resolution of compliance matters; and

Developing and delivering healthcare compliance training programs…