Materials Compliance Manager
Amgen is searching for a Materials Compliance Manager to work in our main corporate campus in Thousand Oaks, CA. The Materials Compliance Manager will report to the Director Materials Compliance.
The Materials Compliance Manager provides clear, decisive leadership and direction to his or her own team as well as the sponsors and reviewers in all phases of educational, promotional, sales training, and RML/disease state material approval.
Responsibilities for the Materials Compliance Manager include:
Managing the materials review process for assigned business units and products.
Represents Material Compliance in process discussions with sponsors and reviewers.
Maintains integrity of neutrality while managing needs of all Material Approval and Compliance (MAC) stakeholders.
Process guidance and direction to sponsors (owners) and to reviewers, as appropriate.
Contributes to the Amgen s compliance initiatives by ensuring that all required promotional materials have undergone MAC review and leads new and ongoing MAC process improvement efforts.
Provides guidance and direction to Traffic Specialist & Technical Editor.
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.
Enforces MAC business rules with reviewers and requesters (project owners).
Builds & maintains strong relationships with project sponsors (owners), reviewers, agencies, third party partners ( e.g. Wyeth) , and business unit compliance lead.
Drives compliance with Amgen review guidelines, MAC Policy, as well as external regulations.
Plans, develops agenda, facilitates, and tracks each MAC meeting.
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 ProjecTrack system.
Oversees creation & dissemination of regular reports to management on process compliance.
Trains and guides all incoming stakeholders through the MAC process.
Master s degree and 2 years of Project Leadership or Supervisory or Management experience
Bachelor s degree and 4 years of Project Leadership or Supervisory or Management experience
Associate s degree and 10 years of Project Leadership or Supervisory or Management experience
High school diploma / GED and 12 years of Project Leadership or Supervisory or Management experience
Pharmaceutical or health care industry experience
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 & prioritize multiple projects
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
Decisive thinker; able to evaluate and interpret complex situations
Strong problem-solving skills
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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