Material Compliance Manager

Material Compliance Manager

Join Amgen's Mission of Serving Patients

At Amgen, our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the worlds 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.

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
• Has a thorough understanding of the BU / product business priorities and translates that information to material approval strategies in support of business objectives
• Ensure MAC business rules with Reviewers and Sponsors
• Works closely with assigned Material Compliance Associates on MAC business and compliance operations
• Builds & maintains strong relationships with project Sponsors, 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

Qualifications

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

Basic Qualifications :

Preferred Qualifications :

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 :

Apply Now and Make a Lasting Impact with the Amgen Team

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.

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.

Sponsorship for this role is not guaranteed.

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.