Senior REMS Risk Management Lead

ClinChoice; United States; On-site; USD 110,000 - 170,000; Full time

Job summary

ClinChoice is seeking a Manager, Risk Management (REMS) Consultant for a 12-month contract with extension potential. This client-facing role supports REMS strategy development, implementation, and operational execution for a sponsor through ClinChoice’s CRO framework.

You will collaborate across QA, PV, and IT to ensure readiness for launches and regulatory submissions, while maintaining compliant documentation and governance across the REMS program.

Qualifications

• Bachelor’s degree in life sciences or equivalent required.
• Strong understanding of REMS, regulatory affairs, pharmacovigilance or related fields.
• Excellent written and verbal English communication.

Responsibilities

• Develop and implement REMS strategies and U.S. risk management plans.
• Coordinate cross-functional REMS operations and governance.
• Prepare status reports, proposals, and regulatory submissions.
• Support inspections, CAPAs, and SOP maintenance.
• Travel up to 10%.

Skills

Cross-functional collaboration

Stakeholder management

Regulatory knowledge (FDA)

Analytical thinking

Education

Bachelor’s degree (life sciences preferred)

Advanced degree (MA, MBA, MHA, PharmD, or similar)

Job description

ClinChoice is seeking a Manager, Risk Management (REMS) Consultant for a 12-month contract with extension potential. This client-facing role supports REMS strategy development, implementation, and operational execution for a sponsor through ClinChoice’s CRO framework.

You will collaborate across QA, PV, and IT to ensure readiness for launches and regulatory submissions, while maintaining compliant documentation and governance across the REMS program.