REMS Strategy & Operations Lead

BioSpace; California; Remoto; USD 142.000 - 212.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical Insurance

Dental Insurance

Vision Insurance

401k

Flexible paid vacation

Descrizione del lavoro

Jazz Pharmaceuticals, a global biopharma company, is seeking a Senior Manager, REMS Operations to oversee U.S. FDA-mandated REMS programs.

You will drive governance, ensure regulatory compliance, and coordinate with internal teams and external vendors to deliver program milestones. You will manage day-to-day REMS operations, monitor program health, mitigate risks, and maintain documentation for inspections, audits, and governance activities.

Competenze

• 4–6 years of experience in the pharmaceutical industry.
• 2 years of pharmaceutical Project/Program Management experience preferred.
• Experience in REMS and vendor management is preferred.
• Proficient in Microsoft Office Suite.

Mansioni

• Manage day-to-day operations of U.S. FDA-mandated REMS programs with compliance.
• Provide strategic oversight of REMS initiatives and objectives.
• Coordinate REMS governance and operational workstreams and minutes.
• Monitor REMS program health, identify risks and mitigation.
• Partner with cross-functional teams and vendors to execute REMS requirements.
• Maintain documentation for inspections, audits and governance activities.

Conoscenze

Communication skills

Organization

Remote work capability

Self-discipline

Microsoft Office

Formazione

Bachelor's degree

Strumenti

Microsoft Office

Descrizione del lavoro

Jazz Pharmaceuticals, a global biopharma company, is seeking a Senior Manager, REMS Operations to oversee U.S. FDA-mandated REMS programs.

You will drive governance, ensure regulatory compliance, and coordinate with internal teams and external vendors to deliver program milestones. You will manage day-to-day REMS operations, monitor program health, mitigate risks, and maintain documentation for inspections, audits, and governance activities.