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In this vital role you 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.
Job Responsibility:
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
Ensure 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
Requirements:
Doctorate degree
OR Master’s degree and 2 years of process, compliance, and/or project management experience
OR Bachelor’s degree and 4 years of process, compliance, and/or project management experience
OR Associate’s degree and 8 years of process, compliance, and/or project management experience
OR High school diploma / GED and 10 years of process, compliance, and/or project management experience
Nice to have:
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 we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
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