Materials Compliance Mgr (Open to Remote)

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Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Materials Compliance Mgr

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for Material Approval and Compliance (MAC) that manages the review and approval process to ensure that only compliant messages are communicated to the public.

• Leads new and ongoing MAC process improvement efforts
• Provides mentorship and direction to MAC Cross Functional team members
• Anticipates process issues and provides solutions for special circumstance reviews due to product launches and regulatory actions (i.e. label changes, fair balance statement, etc.)
• Has a detailed understanding of the BU/product business priorities and translates that information to material approval strategies in support of business objectives
• Implements MAC business rules with reviewers and requesters (project owners)
• Builds & maintains positive relationships with project sponsors (owners), reviewers, agencies, third party partners, and business unit compliance lead
• Drives compliance with Amgen review guidelines, MAC Policy, as well as external regulations
• Facilitates MAC related meetings
• Addresses partner concerns and facilitates a final decision on their resolution
• Uses discretion on which issues to elevate to upper management
• Manages elevation issues to resolution with senior and executive management
• Provides mentorship on the use of Amgens MAC electronic approval system
• Reports to management on process compliance
• Trains and guides all incoming partners through the MAC process

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The compliance professional we seek is a collaborator with these qualifications.

Basic Qualifications:

Doctorate degree OR

Masters degree and 2 years of process, compliance, and/or project management experience OR

Bachelors degree and 4 process, compliance, and/or project management experience OR

Associates degree and 10 process, compliance, and/or project management experience Or

High school diploma / GED and 12 process, compliance, and/or project management experience

Preferred Qualifications:

• Experience in an environment which requires extensive daily examples of negotiation, persuasion, collaboration, and analytical judgment
• Ability to interface and connect with all levels of management
• The skill to be assertive yet extremely tactful
• Ability to communicate and influence all levels of leadership/executive leadership
• Ability to simultaneously manage & prioritize multiple projects
• Strong understanding of process development & process improvement
• Strong project planning, client management and analytical skills
• Excellent oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences
• Being a decisive thinker; able to evaluate and interpret complex situations
• A solid track record of strong problem-solving skills

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

careers.amgen.com

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.