Materials Compliance Manager – Material Approval and Compliance

  • Company: Amgen
  • Posted: January 28, 2017
  • Reference ID: R-33309
Amgen is searching for a Materials Compliance Manager who will be responsible for Material Approval and Compliance (MAC) that manages the review and approval process to ensure that only compliant messages are communicated to the public. This role will report to the Director Materials Compliance in Regulatory Affairs.
The Materials Compliance Manager 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 while managing needs of all MAC stakeholders. The Manager contributes to Amgen's compliance initiatives by ensuring that all promotional materials have undergone MAC review.
Key Activities:
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.)
Translates BU/product business priorities to material approval strategies in support of business objectives
Enforces MAC business rules with reviewers and requesters (project owners)
Builds and 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
Basic 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 10 years of process, compliance, and/or project management experience
High school diploma / GED and 12 years of process, compliance, and/or project management experience
Preferred Qualifications
Experience in an environment with extensive daily examples of negotiation, persuasion, collaboration, and analytical judgment
Ability to interface and communicate with all levels of management
Assertive yet extremely tactful
Ability to communicate and influence all levels of leadership/executive leadership
Ability to simultaneously manage and prioritize multiple projects
Strong understanding of process development and 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
Decisive thinker; able to evaluate and interpret complex situations
Solid track record of strong problem-solving skills
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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, or disability status.

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