Senior REMS Operations Lead — Remote

Jazz Pharmaceuticals, Inc.; Northern (KY); Ibrido; USD 142.000 - 212.000; Tempo pieno

Descrizione del lavoro

Jazz Pharmaceuticals, Inc. is seeking a Senior Manager, REMS Operations to oversee U.S. REMS programs, ensuring regulatory compliance, governance, and operational excellence.

The role drives program delivery, risk mitigation, and cross-functional collaboration across internal teams and external REMS vendors. The position emphasizes strategic oversight, documentation, and continuous process improvement, with remote, home-based work in the United States.

Competenze

• Minimum 4–6 years in the pharmaceutical industry.
• Experience in REMS and vendor management preferred.
• Minimum 2 years in project or program management.
• Excellent written and verbal communication skills.
• Highly organized with strong attention to detail.
• Self-sufficient for a remote work environment.

Mansioni

• Manage day-to-day operations of US REMS programs, ensuring compliance with regulatory requirements and internal governance standards.
• Provide strategic oversight of REMS initiatives, ensuring timely execution of program objectives and alignment to organizational priorities.
• Coordinate REMS governance and operational workstreams, including agenda development, meeting facilitation, timeline management, documentation of meeting minutes, and follow-up on action items with cross-functional stakeholders.
• Monitor overall REMS program health by identifying risks, dependencies, resource constraints, and operational issues, and implement mitigation strategies.
• Partner with cross-functional teams and external vendors to execute REMS program requirements and drive operational excellence.
• Maintain accurate documentation and records to support regulatory inspections, audits, and internal governance activities.

Conoscenze

REMS operations

Vendor management

Project/Program management

Communication skills

Attention to detail

Remote work discipline

Microsoft Office Suite

Formazione

Bachelor's degree

Strumenti

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Descrizione del lavoro

Jazz Pharmaceuticals, Inc. is seeking a Senior Manager, REMS Operations to oversee U.S. REMS programs, ensuring regulatory compliance, governance, and operational excellence.

The role drives program delivery, risk mitigation, and cross-functional collaboration across internal teams and external REMS vendors. The position emphasizes strategic oversight, documentation, and continuous process improvement, with remote, home-based work in the United States.