Manager, Rare Disease Compliance

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manager Rare Disease Compliance

What you will do

Lets do this. Lets change the this vital role you will will serve as a strategic partner to the Rare Disease Business Unit (RDBU) working closely with RDBU leadership to uphold Amgens reputation and advance ethical patient-centric compliance solutions. As part of Amgens Worldwide Compliance & Business Ethics (WC&BE) organization this role supports a strong culture of compliance integrity and ethical decision-making through data-driven insights and proactive engagement.

Reporting to the Senior Director Rare Disease Compliance the Compliance Manager will leverage advanced analytical capabilities (including statistical analysis data mining and predictive modeling) to assess compliance translate insights into actionable recommendations and drive continuous improvement of the RDBU Compliance program.

Key Responsibilities

• 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

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Masters degree and 2 years of experience in compliance risk management regulatory affairs audit law or a related field

Or

Bachelors degree and 4 years of experience in compliance risk management regulatory affairs audit law or a related field

Or

Associates 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

Preferred Qualifications:

• 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 you can expect from us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

Salary Range