Material Compliance Manager

Amgen•Thousand Oaks, CA

About The Position

The Material Compliance Manager is responsible for Material Approval and Compliance (MAC), which manages the review and approval process to ensure that only compliant messages are communicated to the public. Reporting to the Director or Executive Director of Material Compliance in Regulatory Affairs, the manager oversees the materials review process for assigned business units and/or products and represents Material Compliance in process discussions with Sponsors and Reviewers while maintaining neutrality and addressing stakeholder needs. The role contributes to Amgen’s compliance initiatives by ensuring all required promotional materials undergo MAC review. The manager leads process improvement efforts, guides cross-functional team members, supports reviews involving product launches and regulatory actions, and translates business priorities into material approval strategies. The role builds relationships with Sponsors, Reviewers, agencies, third-party partners, and Business Unit Compliance Leads; facilitates meetings and resolutions; manages escalations; supports use of the MAC electronic approval system; reports on process compliance; and trains incoming stakeholders. The listed U.S. annual salary range, excluding Puerto Rico, is $105,697.50–$143,002.50. Actual salary varies based on factors including relevant skills, experience, and qualifications. Amgen describes a Total Rewards Plan that may include benefits, incentives, flexible work models where possible, and career development opportunities.

Requirements

Doctorate degree.
Alternatively, a master’s degree and 2 years of process, compliance, and/or project management experience.
Alternatively, a bachelor’s degree and 4 years of process, compliance, and/or project management experience.
Alternatively, an associate degree and 8 years of process, compliance, and/or project management experience.
Alternatively, a 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.
A solid track record of strong problem-solving skills.

Responsibilities

Lead new and ongoing MAC process improvement efforts.
Provide guidance and direction to MAC cross-functional team members.
Anticipate process issues and provide solutions for special-circumstance reviews, including those related to 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 strong relationships with project Sponsors, Reviewers, agencies, third-party partners, and Business Unit Compliance Leads.
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 use of Amgen’s MAC electronic approval system.
Report to management on process compliance.
Train and guide incoming stakeholders through the MAC process.

Benefits

Health and welfare plans for staff and eligible dependents.
Retirement and Savings Plan with company contributions.
Group medical coverage.
Dental coverage.
Vision coverage.
Life insurance.
Disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Time-off plans.
Flexible work models where possible.
Career development opportunities.