Manager, REMS Center of Excellence

Vaga não está no LinkedIn

🕒 Junho 11

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $91.400 - $169.700 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

👔 Gerente

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Sandoz

SiteLinkedInTodas as Vagas

10.000+ funcionários

💊 Farmacêutico

🧬 Biotecnologia

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

<Sandoz> Sandoz é uma empresa farmacêutica global focada no desenvolvimento, fabricação e fornecimento de medicamentos genéricos e biossimilares para melhorar o acesso dos pacientes a tratamentos acessíveis e de alta qualidade. A empresa dá ênfase à qualidade de fabricação, conformidade regulatória e parcerias, atendendo sistemas de saúde, hospitais e outros clientes comerciais, ao mesmo tempo que avança em iniciativas de sustentabilidade, ética e acesso.

Descrição

• Work collaboratively with internal and external stakeholders to manage Risk Evaluation and Mitigation Strategies (REMS) in the Sandoz generic and biosimilar portfolios • Serve as the Sandoz safety REMS expert on project/product teams throughout the product life cycle • Provide oversight of the tactical implementation and monitoring of REMS commitments • Develop and manage vendor contracts with the support of project teams • Ensure compliance with REMS regulatory requirements and reporting • Contribute to the development and implementation of innovative, evidence-based risk management solutions • Drive execution of REMS development, implementation, and operationalization according to agreed upon strategies

🎯 Requisitos

• RN, MS, MPH, MBA, or BS with considerable experience • Minimum of 2 years supporting REMS programs • Advanced knowledge of FDA REMS requirements, regulatory expectations, and evolving risk-mitigation standards • Skilled in establishing productive relationships with vendors, healthcare partners, and internal teams • Expertise in streamlining workflows, optimizing resource allocation, and leveraging data-driven decision-making • Deep understanding of project management methodologies and best practices • Ability to develop and execute high-level strategies for product launches • Up to 10% travel required

🏖️ Benefícios

• health insurance coverage for medical, prescription drugs, dental and vision • a generous company match for retirement savings accounts • generous paid time off • follow a hybrid work policy that combines a mix of in-person and remote work to allow our employees flexibility