Compliance Manager

April 8

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Amgen

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Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

📋 Description

• Promote and support adherence to all U.S. Healthcare Compliance requirements. • Assist US Compliance Leads in implementing and administering Amgen’s Corporate Compliance programs & policies • Provide advice, guidance and support to staff and management on interpretation and implementation of Amgen policies & procedures • Maintain awareness of applicable laws and regulatory guidance that may affect Amgen’s Compliance program • Develop training programs, materials and workshops aligned with Amgen procedures & policies and deliver to appropriate audience • Gather documentation and assist with risk assessment and management activities to help identify potential areas of improvement opportunities and risk • Participate, track and provide feedback on improvement actions • Analyze key performance indicators and business data to formulate and integrate compliance metrics into trend analyses and reports • Establish productive working relationships with business partners throughout the company • Perform compliance assessments, generate contracts, and submit payment requests consistent with Amgen’s Healthcare Compliance Policy and Standard Operating Procedures • Manage compliance processes relating to Amgen’s interactions with Healthcare Professionals • Interact with the business to ensure compliance processes and standards are understood and followed.

🎯 Requirements

• Doctorate degree • Or Master’s degree and 2 years of Compliance, Regulatory or Legal experience • Or Bachelor’s degree and 4 years of Compliance, Regulatory or Legal experience • Or Associate’s degree and 8 years of Compliance, Regulatory or Legal experience • Or High school diploma / GED and 10 years of Compliance, Regulatory or Legal experience • 3 years of Pharmaceutical/Biotech industry experience, particularly in Compliance, Legal, Audit, Monitoring, Regulatory Affairs, or cross-functional experience in Sales, Marketing, or Medical • Knowledge and understanding of Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, • Pharmaceutical Research and Manufacturers of American (PhRMA) Code, • U.S. Federal Anti-Kickback Statute, • current Corporate Integrity Agreements (CIAs), • Accreditation Council for Continuing Medical Education (ACCME) guidelines, • Prescription Drug Marketing Act, • FDA commercial guidelines, • data privacy, • and U.S. Federal and State transparency reporting requirements • Ability to think strategically and to translate strategy into action plans • Experience with Microsoft Excel, Word, Outlook, and PowerPoint • Excellent written and verbal communication skills • Ability to prioritize, be proactive, resolve conflicts, meet deadlines, follow through on assignments, and work independently and in teams • Ability to work independently and understand, follow and implement complex instructions • Strong organizational skills, attention to detail, and on-time delivery of work product • Ability to generate reports and prepare formal presentations for required forums

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, • group medical, dental and vision coverage, • life and disability insurance, • flexible spending accounts • A discretionary annual bonus program, • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models, including remote and hybrid work arrangements, where possible