Manager, REMS Center of Excellence

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $91.4k - $169.7k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

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Sandoz

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

<Sandoz> Sandoz is a global pharmaceuticals company focused on developing, manufacturing and supplying generic medicines and biosimilars to improve patient access to affordable, high-quality treatments. The company emphasizes manufacturing quality, regulatory compliance, and partnerships, and serves healthcare systems, hospitals, and other commercial customers while advancing sustainability, ethics, and access initiatives.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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