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The purpose of the Global Labeling (GL) group is to develop and maintain core labeling documents to provide quality product labels and drive global labeling strategy to ensure safe and effective use of Amgen products for patients and healthcare providers around the world. As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, the Labeling Strategist, Manager is responsible for supporting the facilitation and management of the end-to-end labeling processes for the pre & post marketed products over the products life cycle. The Labeling Strategist, Manager will support the development of the Core Labeling documents and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s).
Job Responsibility:
Authors 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
Nice to have:
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
What we offer:
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, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan