Materials Compliance Mgr (Open to Remote)
Amgen
2021-11-03T22:03:01Z
Virginia Beach
Virginia
United States
Customer Service / Call Center
(No Timezone Provided)
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, 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
Let’s do this. Let’s 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 Amgen’s 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
Master’s degree and 2 years of process, compliance, and/or project management experience OR
Bachelor’s degree and 4 process, compliance, and/or project management experience OR
Associate’s 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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with 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
Materials Compliance Mgr (Open to Remote)
Customer Service / Call Center
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, 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
Let’s do this. Let’s 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 Amgen’s 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
Master’s degree and 2 years of process, compliance, and/or project management experience OR
Bachelor’s degree and 4 process, compliance, and/or project management experience OR
Associate’s 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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with 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