Material Compliance Manager

Amgen • Los Angeles, CA

7d • $105,698 - $143,003

About The Position

Amgen is seeking a Material Compliance Manager for Material Approval and Compliance (MAC) in Regulatory Affairs. The role manages reviews and approvals to ensure that only compliant messages are communicated to the public, and ensures required promotional materials undergo MAC review. The Manager oversees the materials review process for assigned business units and/or products, represents Material Compliance in process discussions with Sponsors and Reviewers, and maintains neutrality while addressing stakeholder needs. The position reports to the Director or Executive Director of Material Compliance.

Requirements

• Doctorate degree; no additional experience requirement is specified for this education level.
• 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 or GED and 10 years of process, compliance, and/or project management experience.

Nice To Haves

• Experience in an environment requiring extensive daily negotiation, persuasion, collaboration, and analytical judgment.
• Ability to interface and communicate with all levels of management.
• Ability to be assertive while remaining extremely tactful.
• Ability to communicate with and influence all levels of leadership, including executive leadership.
• Ability to manage and prioritize multiple projects simultaneously.
• Experience supervising staff.
• Strong understanding of process development and process improvement.
• Strong project planning, client management, and analytical skills.
• Excellent oral, written, and presentation skills, including the ability to explain complex concepts clearly to varied audiences.
• Decisive thinking and ability to evaluate and interpret complex situations.
• Strong problem-solving track record.

Responsibilities

• Lead new and ongoing MAC process improvement efforts.
• Provide guidance and direction to MAC cross-functional team members.
• Anticipate process issues and develop solutions for special-circumstance reviews, including product launches and regulatory actions such as label changes and fair-balance statements.
• Understand business-unit and product priorities and translate them into material-approval strategies that support business objectives.
• Enforce MAC business rules with Reviewers and Sponsors (project owners).
• Work closely with assigned Material Compliance Associates on MAC business and compliance operations.
• Build and maintain relationships with project Sponsors, Reviewers, agencies, third-party partners, and the Business Unit Compliance Lead.
• Drive compliance with Amgen review guidelines, MAC Policy, and external regulations.
• Facilitate MAC-related meetings.
• Address stakeholder concerns and facilitate final decisions on their resolution.
• Use discretion in determining which issues to elevate to upper management.
• Manage escalated issues through resolution with senior and executive management.
• Guide users on Amgen’s MAC electronic approval system.
• Report on process compliance to management.
• Train and guide incoming stakeholders through the MAC process.

Benefits

• Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed