Sr. Manager, U.S. Healthcare Compliance

Career Category

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.

Senior Manager, U.S. Healthcare Compliance

What you will do

Let’s do this! Let’s change the world! In this vital role the Sr. Manager, U.S. Healthcare Compliance will serve as the primary compliance point of contact for Amgen's U.S. Value & Access, Market Access & Contracting, and Patient Access & Reimbursement teams. They will ensure that the organization is in compliance with all relevant laws and regulations and will develop and implement policies and practices to ensure compliance while educating employees about compliance requirements and responding to compliance issues as they arise.

Under the direction of the Executive Director, U.S. Healthcare Compliance, this individual will be asked to work with various cross-functional organizations including Law, Regulatory, and Privacy to appropriately advise the business on how best to mitigate risk related to key strategic initiatives.

This individual will rely on his or her understanding and knowledge of the U.S. enforcement environment regarding biopharmaceutical products with particular experience in interpreting:

• FDA drug promotional requirements

• Federal False Claims Act

• Federal anti-kickback statute

• U.S. privacy requirements

• Government transparency reporting

• Industry standards for compliance and ethics (PhRMA Code)

This Sr. Manager, U.S. Healthcare Compliance will also rely on their understanding of the commercial environment regarding Amgen products including the following areas:

• Competitive products

• Clinical and scientific data

• Issues surrounding the value assessment of Amgen products

• Challenges to patient and provider access to medicines

• Other medical advancements and developments in the disease areas of interest for Amgen

Note: Not for Quality Function

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The compliance professional we seek will have these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of experience in compliance or legal supporting bio-pharmaceutical business

Or

Master’s degree and 4 years of experience in compliance or legal supporting bio-pharmaceutical business

Or

Bachelor’s degree and 6 years of experience in compliance or legal supporting bio-pharmaceutical business

Or

Associate’s degree and 10 years of experience in compliance or legal supporting bio-pharmaceutical business

Or

High school diploma / GED and 12 years of experience in compliance or legal supporting bio-pharmaceutical business

Preferred Qualifications:

• Proven skills in delivering strategies and results in a complex organization

• Ability to prioritize work-related tasks and effectively communicate with leadership

• Strong written, spoken and interpersonal communication skills with attention to detail; polished, poised presenter

• Ability to efficiently navigate an exciting and dynamic environment

• Strong critical thinking, problem-solving and planning skills

• Collaboratively work with a diverse group of people and backgrounds

• Entrepreneurial spirit, passion and creativity

What you can expect of 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, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (e