Amgen

Labeling Strategist, Manager

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $113,411 - $155,526 per year

About the role

  • Authors (user friendly, international language, consistent across products) and maintains core labeling documents including cCDS, cPIL, and cIFU in addition to dCDS, dIFU, USPI, and medguide
  • Chairs/leads the Labeling Working Group, and presents to Executive Labeling Board
  • Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends
  • Advises internal and/or external specialists on the creation of high quality documents supporting changes to the core labeling documents and runs the annotations within those documents
  • Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies.
  • Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies
  • Represents labeling on product-specific global regulatory teams

Requirements

  • Doctorate degree OR Master’s degree and 2 years of related experience OR Bachelor’s degree and 4 years of related experience OR Associate’s degree and 10 years of related experience OR High school diploma / GED and 12 years of related experience
  • Degree in pharmaceuticals, natural science or medicine
  • Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
  • Knowledge of labeling within a Therapeutic Area
  • Knowledge of FDA, or EMA, or other international regulations for labeling
  • Collaboration, presentation, communication, interpersonal, and leadership skills
  • Experience working in a Documentum-based document management system.
Benefits
  • 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
  • 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 where possible.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
labeling documentscCDScPILcIFUdCDSdIFUUSPImedguidelabeling regulationslabeling trends
Soft Skills
collaborationpresentationcommunicationinterpersonal skillsleadership