REMS Strategy & Operations Leader

Jazz Pharmaceuticals, Inc.; California; Remoto; USD 142.000 - 212.000; Tempo pieno

Descrizione del lavoro

Jazz Pharmaceuticals, Inc. seeks a Senior Manager to lead REMS Operations, overseeing FDA-mandated REMS programs in the U.S. You will ensure regulatory compliance, drive governance, manage vendor relationships, and coordinate cross-functional execution.

This role requires 4–6 years in pharma and 2+ years in project/program management, with strong MS Office skills and proven organizational abilities for a remote work environment.

Competenze

• 4–6 years in the pharmaceutical industry.
• REMS and vendor management experience preferred.
• 2+ years of pharmaceutical Project/Program Management experience.
• Proficient with Microsoft Word, Excel, PowerPoint, Outlook.
• Excellent written and oral communication skills.
• Highly organized with attention to detail; able to work remotely.

Mansioni

• Manage day-to-day operations of the US FDA–mandated REMS programs, ensuring regulatory compliance.
• Provide strategic oversight of REMS initiatives and align with priorities.
• Coordinate REMS governance and workstreams, agenda, minutes, and action items.
• Monitor program health, identify risks and dependencies, mitigate issues.
• Collaborate with cross-functional teams and external vendors to execute REMS requirements.
• Maintain documentation for inspections, audits and governance activities.

Conoscenze

REMS programs

Vendor management

Project/Program management

Communication

Attention to detail

Remote work discipline

Formazione

Bachelor's degree

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Descrizione del lavoro

Jazz Pharmaceuticals, Inc. seeks a Senior Manager to lead REMS Operations, overseeing FDA-mandated REMS programs in the U.S. You will ensure regulatory compliance, drive governance, manage vendor relationships, and coordinate cross-functional execution.

This role requires 4–6 years in pharma and 2+ years in project/program management, with strong MS Office skills and proven organizational abilities for a remote work environment.