Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Combination Product Safety- Senior Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide science-based evaluation of the safety of combination products, medical devices, companion diagnostics and digital health for Amgen products

• Assessment of potential impact of quality findings on patient/user safety for all Amgen clinical and commercial combination products and medical devices
• Review of adverse event data to detect potential product quality issues for Clinical and commercial products
• Provision of expertise in combination product safety data collection / analysis and reporting for commercial products and in clinical trials
• Provide science-based input on the development including in the risk management of combination products and medical devices

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Combination Product Safety- Senior Manager professional we seek is a Senior Manager with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of safety experience

OR

Master’s degree and 6 years of safety experience

OR

Bachelor’s degree and 8 years of safety experience

Preferred Qualifications:

• Bachelor’s degree or greater in a life science discipline with experience in pharmaceutical/biotechnology/medical devices and combination products.
• Demonstrated relevant scientific training OR clinical experience in activities relevant to utilization of combination products, medical devices and/or companion diagnostics (nursing, study management, pharmacist, etc.)
• Previous experience creating Medical Opinion Memos, Health Hazard Assessments, or Medical Inputs for product complaints.
• Knowledge of clinical trials, medical device and combination product safety monitoring, regulations, and standards
• Knowledge of medical device and combination product development including but not limited to design controls, Quality Management Systems, and other relevant standards and regulations.

Knowledge of device risk management methodology, standards, and tools

Knowledge of post market safety reporting regulations/guidelines for medical devices/combination products globally.

Knowledge of signal detection principles for drugs/biologics.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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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.

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.

Salary Range