Manager, REMS Center of Excellence

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🕒 2 dias atrás

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $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

• 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 • Work closely with internal business units, including Regulatory Affairs, Medical Affairs, Legal, and Pharmacovigilance • Drive execution of REMS development, implementation, and operationalization according to agreed strategies • Develop and manage vendor contracts • Manage REMS budgets, review and approve vendor invoices, and program deliverables • Ensure compliance with REMS regulatory requirements and reporting • Coordinate REMS training across the organization

🎯 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 • Minimum of 5 years in pharmaceutical industry (preferred)

🏖️ Benefícios

• Health insurance coverage for medical, prescription drugs, dental and vision • Generous company match for retirement savings accounts • Generous paid time off • Hybrid work policy that combines a mix of in-person and remote work