Materials Compliance & MAC Lead

Amgen SA; Los Angeles (CA); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

Retirement and savings plan

Stock-based long-term incentives

Flexible work models

Healthcare benefits

Job summary

Amgen seeks a Materials Compliance Manager to lead MAC processes, manage cross-functional teams, and ensure compliant promotional materials. The role reports to the Director/Executive Director of Material Compliance in Regulatory Affairs and collaborates with Sponsors, Reviewers, and MCA staff.

Strong leadership, project management, and regulatory knowledge are essential to drive MAC strategy, escalate issues, and uphold Amgen’s compliance standards across units.

Qualifications

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

Responsibilities

• Leads 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
• 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

Skills

Negotiation

Persuasion

Collaboration

Analytical judgment

Leadership

Communication

Project management

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen seeks a Materials Compliance Manager to lead MAC processes, manage cross-functional teams, and ensure compliant promotional materials. The role reports to the Director/Executive Director of Material Compliance in Regulatory Affairs and collaborates with Sponsors, Reviewers, and MCA staff.

Strong leadership, project management, and regulatory knowledge are essential to drive MAC strategy, escalate issues, and uphold Amgen’s compliance standards across units.