Manager, REMS Center of Excellence

Job not on LinkedIn

🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $91.4k - $169.7k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• 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

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

🏖️ Benefits

• 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