Manager, REMS Operations

Jazz Pharmaceuticals

Manager overseeing FDA-mandated REMS operations for Jazz Pharmaceuticals, a global biopharma company developing medicines for serious diseases. Coordinating governance, compliance, materials, vendors, and regulatory documentation.

Posted 8/4/2026full-timeRemote • California, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $128,000 - $192,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing U.S. FDA-mandated REMS programs, ensuring compliance with regulatory requirements, and coordinating cross-functional teams. Proficient in project management, documentation, and communication within the pharmaceutical industry.

Highest-signal resume keywords

REMS Program ManagementPharmaceutical Project ManagementRegulatory ComplianceMicrosoft Office ProficiencyExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

REMS Program ManagementPharmaceutical Project ManagementRegulatory ComplianceDocumentation ManagementRisk IdentificationMitigation StrategiesAgenda DevelopmentMeeting FacilitationTimeline ManagementAction-Item Follow-Up

Soft Skills

Highly OrganizedAttention to DetailSelf-SufficientDisciplined

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

Pharmaceutical IndustryFDA RegulationsREMSGovernance StandardsOperational Issues

About the role

Key responsibilities & impact

Support the day-to-day operations of U.S. FDA-mandated REMS programs and ensure compliance with regulatory requirements and internal governance standards
Provide strategic oversight of REMS initiatives and align program execution with organizational priorities
Coordinate REMS governance and operational workstreams, including agenda development, meeting facilitation, timeline management, meeting minutes, and action-item follow-up
Monitor REMS program health by identifying risks, dependencies, resource constraints, and operational issues
Implement mitigation strategies to support business continuity
Support development, staging, review, communication, and approval of REMS materials
Partner with cross-functional teams and external vendors to execute REMS program requirements
Maintain accurate documentation and records for regulatory inspections, audits, and internal governance activities

Requirements

What you’ll need

4–6 years of experience in the pharmaceutical industry
Minimum 2 years of pharmaceutical project and/or program management experience
Experience in REMS preferred
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
Excellent oral and written communication skills
Highly organized with consistent attention to detail
Self-sufficient and disciplined for a remote work environment
Bachelor's degree or equivalent in a relevant field required

Benefits

Comp & perks

Discretionary annual cash bonus or incentive compensation
Discretionary equity grants
Medical insurance
Dental insurance
Vision insurance
401k retirement savings plan
Flexible paid vacation