Labeling Strategist – Manager

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $112 744 - $152 536 / an

⏰ Temps Plein

🟢 Junior

🟡 Intermédiaire

👔 Manager

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Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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.