Material Compliance Manager

Career Category

Regulatory

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Material Compliance Manager

What you will do

Let’s do this. Let’s change the world. Materials Compliance Manager who 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. This role will report to the Director or Executive Director of Material Compliance in Regulatory Affairs.

The Materials Compliance Manager will manage the materials review process for assigned business units and/or products. The Manager will represent Material Compliance in process discussions with Sponsors and Reviewers and maintains integrity of neutrality while managing needs of all MAC stakeholders. The Manager contributes to Amgen’s compliance initiatives by ensuring that all required promotional materials have undergone MAC review.

Key Responsibilities

• Leads new and ongoing MAC process improvement efforts
• Provides guidance 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 thorough understanding of the BU/product business priorities and translates that information to material approval strategies in support of business objectives ● Enforces MAC business rules with Reviewers and Sponsors (project owners)
• Works closely with assigned Material Compliance Associates (MCA) on MAC business and compliance operations
• Builds & maintains strong 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 stakeholder 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 guidance on the use of Amgen’s MAC electronic approval system

• Reports to management on process compliance
• Trains and guides all incoming stakeholders through the MAC process

What we expect of you

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

Basic Qualifications

• Doctorate degree
• undefined
• Master’s degree and 2 years of process, compliance, and/or project management experience
• undefined
• Bachelor’s degree and 4 years of process, compliance, and/or project management experience
• undefined
• Associate’s degree and 8 years of process, compliance and/or project management experience
• undefined
• High school diploma / GED and 10 years of 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 communicate 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
• Supervision of staff
• 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

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.

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