Material Compliance Associate at Amgen
Washington, DC 20004, USA -
Full Time


Start Date

Immediate

Expiry Date

29 Oct, 25

Salary

87441.0

Posted On

29 Jul, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Excel, Outlook, Approval Process, Powerpoint, Marketing Materials, Regulatory Guidelines, Adobe Photoshop, Ged, Microsoft Office, Materials, Commercialization

Industry

Marketing/Advertising/Sales

Description

Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Material Compliance Associate

BASIC QUALIFICATIONS:

  • Bachelor’s degree OR
  • Associate’s 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:

  • An understanding of the pharmaceutical commercialization process and knowledge of the legal and regulatory guidelines affecting promotion of prescription products
  • Project management experience in the Pharmaceutical, Biotechnology, Healthcare-related field, or other regulated industries
  • 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
  • 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
Responsibilities

Let’s do this. Let’s change the world. In this vital role you will be responsible for assisting the Brand Marketers build and monitor 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.

Responsibilities

  • Supports one Material Approval and Compliance (MAC) Team.
  • Supports Global Initiative/Other Project.
  • Quality check submissions for review to ensure alignment with internal standards throughout the process.
  • Work with agencies and internal staff, including training on next steps and advising on process standards.
  • Collaborates with MRL to identify Reference QC issues and Match Text Harvesting
  • 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.
  • Actively listen to and capture comments from meeting stakeholders.
  • Anticipate edits and work proactively to suggest solutions.
  • Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver on-time.
  • Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills.
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