Labeling Strategist – Manager

🕒 Maio 6

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $112.744 - $152.536 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

👔 Gerente

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Biotechnology • Pharmaceuticals • Science

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• The purpose of the Labeling Strategy and Compliance (LSC) group is to develop and maintain quality core and regional labeling documents and drive global labeling strategy. • Leads the development of the Core Labeling documents and US Labeling deliverables in accordance with Amgen Labeling Processes. • Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings. • Ensures deviations from labeling procedures and policies are escalated appropriately. • Manages the review and approval of core DHCP letters. • 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.

🎯 Requisitos

• 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 8 years of related experience OR High school diploma / GED and 10 years of related experience • Degree in life science or medicine • Experience in Pharmaceutical Industry Regulatory Affairs and /or product labeling • Expertise in product labeling within a Therapeutic Area • Knowledge of FDA, EMA, and other international regulations for labeling • Project Management Skills • Understands the impact of emerging trends and their implications for Amgen • Experience in managing individual and group projects of high to moderate complexity • Experience working in a Veeva/Documentum-based document management system.

🏖️ Benefícios

• 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.