R&D Supplier Governance Monitor

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.

R&D Supplier Governance Monitor

What you will do

Let’s do this. Let’s change the world. In this vital role you will support Amgen-sponsored clinical trials worldwide. Reporting to the Senior Manager of R&D Supplier Governance, you will help ensure the quality and integrity of processes and data generated by service suppliers for these trials. Additionally, as part of the RDSG team, you will support programs and study teams, collaborate with senior management, and partner with internal stakeholders and suppliers for process improvement.

We support our clinical trials around the world. Come join an outstanding team that delivers for our study teams and our patients! Potentially up to 25% travel domestic and/or international.

Responsibilities

• Monitoring the collection, processing, and analysis of data by Service Suppliers for Amgen sponsored clinical trials

• Monitoring and evaluating Supplier compliance and data quality

• Tracking corrective actions in relation to monitoring issues and audit findings; escalates as appropriate

• Developing professional relationships with service suppliers and with Amgen stakeholders

• Driving continuous improvement

• Communicating identified issues to key stakeholders at the supplier and at Amgen

• Facilitating and implementing supplier governance meetings, operating reviews, monitoring key performance indicators and perform issue management

• Build and maintain relationships with key internal and external partners, including study teams, functional leads, procurement, quality, compliance, and suppliers

• Support business functions with evaluation, selection, and startup of suppliers

Ensure quality oversight of vendors though:

• Working with suppliers and internal customers (typically up to Director level) to identify, lead, raise and resolve issues related to supplier performance

• Measuring supplier performance and reporting performance feedback to internal partners and supplier

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a monitor with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree & 2 years of relevant experience OR

• Bachelor’s degree & 4 years of relevant experience OR

• Associate’s degree & 8 years of relevant experience OR

• High school diploma / GED & 10 years of relevant experience

Preferred Qualifications:

• BA/BS/BSc in the sciences or RN

• 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical trial experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company).

• Experience at, or oversight of, technical suppliers (imaging and/or adjudication).

• Experience working in a global, matrix organization.

• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines.

• Project management/project planning experience.

• Proficiency in anticipating and resolving problems.

• Experience writing and communicating clearly on scientific and clinical issues.

• Excellent interpersonal, organizational, supervisory skills.

• Professional collaboration and leadership skills.

• Experience in compliance, quality, and audit

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, we’ll 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, including remote and hybrid work arrangements, where possible

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

careers.amgen.com

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.

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