Material Compliance Associate

Amgen Inc.

3.6

(9)

Thousand Oaks, CA

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-182317

    Position summary

    itor their projects through the Material Approval and Compliance (MAC) review process. The MCA will quality check files submitted for review, collect "live" edits during compliance review and approval meetings, and edit submission documents within the electronic review system, Veeva. They will ensure all materials submitted adhere to Amgen MAC Standards and FDA requirements throughout the process.

    • Quality check submissions for review to ensure alignment with internal standards

    • Work with agencies and internal staff, including training on next steps and advising on process standards

    • Provide administrative support during review meetings, including gathering "live" edits on submission documents

    • Assist with Label updates

    • Periodically assist on a variety of MAC-related projects

    • Run Veeva reports and communicate outputs to cross-functional partners

    • Proofreading commercial and training materials produced by the Marketing teams

    • Revise documents electronically

    Other skills

    • Actively listen to and capture comments from meeting stakeholders

    • Anticipate edits and work proactively to suggest solutions

    • Ability to champion collaboration, work effectively on cross-functional teams, and consistently deliver timely

    • Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills

    • Critical thinking and problem-solving skills

    • Quick learner, proactive, takes initiative

    • Able to distinguish an accurate balance between strategic and tactical thinking

    • Strong experience with Project Management tools, methodologies, and practices

    • Proven ability to manage in a highly fluid, interactive, matrix environment

    • Experience with Microsoft Office 365 (e.g. Word, Excel, Outlook, and PowerPoint), Adobe products (e.g. Adobe Photoshop, Illustrator, and Acrobat Pro), and Veeva PromoMats

    • Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest, and assemble information to enable relevant business analysis and influence decision-making

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

    Basic Qualifications:

    • Bachelor's degree

    Or

    • Associates degree and 4 years of Marketing Communications Project Management / Copy-Editing experience

    Or

    • High school diploma, or GED, and 6 years of Marketing Communications Project Management / Copy-Editing experience

    Preferred Qualifications:

    • Project management experience in the Pharmaceutical, Biotechnology, Healthcare-related field or other regulated industries

    • Experience in leading the creation of marketing materials from concept to commercialization

    • Experience managing the approval process of marketing materials that are produced at high volumes.

    • Copy-Editing experience including excellent typing and spelling skills

    • Able to proofread materials using Adobe Acrobat Professional

    Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

    Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

    • 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 and bi-annual company-wide shutdowns

    • Flexible work models, including remote work arrangements, where possible

    Apply now

    for a career that defies imagination

    Objects in your future are closer than they appear. Join us.
    careers.amgen.com

    Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

    We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

    Salary Range
    72,515.00 USD - 83,849.00 USD

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging