Director, Global Labeling

🕒 2 dias atrás

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Eisai US

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1995

💊 Farmacêutico

🏥 Saúde

Pharmaceuticals • Healthcare

A Eisai US é a filial nos Estados Unidos da Eisai Inc. , uma empresa farmacêutica global focada em pesquisar, desenvolver, fabricar e comercializar medicamentos — especialmente em neurologia (incluindo a doença de Alzheimer) e oncologia. Com quase 40 anos de presença em P&D e manufatura nos EUA, a Eisai US conduz ensaios clínicos, programas de apoio ao paciente, engajamento comunitário e iniciativas de responsabilidade corporativa sob sua missão de "assistência à saúde humana", e enfatiza um pipeline orientado pela ciência e colaborações para atender áreas de alta necessidade médica.

Descrição

• Shape and execute global regulatory labeling strategies supporting business objectives and patient needs • Oversee direct product responsibilities and a team of Labeling Strategists • Develop and maintain labeling documents for US, EU, Growth, and Rest of World markets • Lead cross-functional teams developing content for new or revised CCDS, USPI, EU SmPC, and other market labels • Liaise between co-promote partners and Eisai stakeholders • Establish and maintain global labeling processes and standards • Operationalize labeling activities across products • Maintain the centralized global labeling repository in Eisai’s electronic document management system • Manage labeling development, review, and approval workflows • Track timely and consistent implementation of safety changes in local labels • Provide labeling support for US and EU Packaging Engineering functions on artwork control and approval • Ensure consistency and regulatory compliance across product labeling • Analyze competitor labeling to maintain competitive Eisai product labeling • Maintain expertise in worldwide labeling requirements and applicable regulatory guidelines • Represent global regulatory labeling on international project teams and contribute strategic input to TPP, CCDS, USPI, EU SmPC, and Country Product Information development and approval • Support resource management, performance management, coaching, mentoring, and people development for US and UK labeling professionals

🎯 Requisitos

• Bachelor's degree in life sciences required • Higher degree preferred • Minimum of 10 years of experience in Regulatory, R&D, or related areas • Pharmaceutical experience required • Solid working knowledge of the drug development process • Solid working knowledge and experience of global regulatory labeling environments and requirements • Solid knowledge and demonstrated ability to apply regulatory guidelines pertaining to product labeling • Strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal, and communication skills • Ability to work under tight timelines and thrive under pressure • Attention to detail and ability to articulate findings

🏖️ Benefícios

• Annual Incentive Plan eligibility • Long Term Incentive Plan eligibility • Company employee benefit programs • Additional benefits may be available • Equal opportunity and disability accommodation support