Manager, Rare Disease Compliance Job at Amgen

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.

Job Responsibility

Explores and adopts new AI tools and emerging technologies to support and enhance compliance monitoring, reporting, and operational efficiency within RDBU
Identifies opportunities to automate routine tasks and improve data-driven decision-making tailored to the needs of RDBU
Drives process improvements by identifying inefficiencies in compliance workflows, recommending and implementing enhancements, and supporting change management efforts to strengthen the compliance framework
Conducts data analyses across multiple compliance workstreams, systems, and other information sources to identify emerging patterns, trends, and potential risks
Designs and supports AI-driven monitoring approaches and automated reporting solutions, in partnership with relevant data and technology teams
Develops and maintains a streamlined approach to providing the compliance team, RDBU leadership, and cross-functional partners with high-impact compliance data and information to accelerate insights, and facilitate programmatic and operational improvements
Creates clear, compelling data narratives (through written reports and executive-level presentations) that effectively communicate findings and observations to RDBU leadership so that practical recommendations may be formulated
Translates data-driven insights into compliance learnings that inform training materials, communications, and field-facing guidance for RDBU teams
Performs field engagement initiatives (including monitoring and training activities) that reinforce ethical decision-making and adherence to Amgen policies
Partners with Communications and Training teams to support consistent, effective compliance messaging and education across RDBU
Ensures compliance findings, mitigation plans, and corrective action are appropriately documented, tracked to completion, and periodically reassessed to validate sustained compliance
Monitors industry-wide compliance and enforcement trends
Supports additional projects and priorities as assigned by the Senior Director, Rare Disease Compliance
Travels as needed to conferences, internal training, and/or meetings to support RDBU Compliance initiatives
Serves as a role model for ethical and compliant behavior within Amgen

Requirements

Doctorate degree
OR Master’s degree and 2 years of experience in compliance, risk management, regulatory affairs, audit, law, or a related field
OR Bachelor’s degree and 4 years of experience in compliance, risk management, regulatory affairs, audit, law, or a related field
OR Associate’s degree and 8 years of experience in compliance, risk management, regulatory affairs, audit, law, or a related field
OR High school diploma / GED and 10 years of experience in compliance, risk management, regulatory affairs, audit, law, or a related field

Nice to have

In-depth knowledge of U.S. and international healthcare compliance laws and standards (e.g., Anti-Kickback Statute, False Claims Act, Sunshine Act, GDPR) and other applicable standards
Familiarity with industry codes of conduct (e.g., PhRMA)
Strong understanding of compliance risk areas, including promotional practices, HCP interactions, and third-party oversight
Fluency in English and at least one regional language
Proficient in using technology, analytics, and AI-driven tools for compliance monitoring, risk assessment, and process improvement tailored to regional requirements
Demonstrated curiosity and willingness to experiment with innovative compliance technologies, such as automation, AI, or data visualization platforms
Strong project management skills, with the ability to manage multiple assignments, prioritize effectively, and deliver results in a dynamic, fast-paced environment
Able to communicate compliance concepts clearly and concisely to diverse audiences, including regional management and cross-functional teams
Demonstrated ability to build effective working relationships and collaborate across teams in a global, matrixed organization, with sensitivity to regional cultural and regulatory differences
Experience with compliance management systems, data visualization, and reporting tools (e.g., Tableau, Power BI, GRC platforms)
Adaptable and eager to learn new technologies and regulatory trends impacting regional compliance
High ethical standards, integrity, and sensitivity to diverse groups, with the ability to influence and resolve conflict constructively

What we offer

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, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

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Manager, Rare Disease Compliance

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