Project Manager, REMS Team - Remote based in the US
Core
Lead cross-functional project delivery for Risk Evaluation Mitigation Strategy (REMS) initiatives, ensuring quality, time, and cost objectives are met for sponsors.
Role type
Senior REMS Project Manager
Builds
REMS project deliverables and compliance outcomes
Domain
Life Sciences / Clinical Development / Regulatory Affairs
Deliverable
client delivery
Required skills
REMS project management, financial stewardship, risk identification and issue resolution, contract management, cross-functional team leadership, regulatory compliance (ICH-GCP), therapeutic area knowledge
Preferred skills
Vendor management, negotiation, strategic thinking, cultural awareness
Technologies
Microsoft Office Suite, CTMS, Preclarus, Clarity
Responsibilities
Serve as primary sponsor contact, manage project budget and resources, drive risk identification and issue resolution, ensure team compliance with SOPs and regulations, lead cross-functional teams to meet deliverables
Seniority
Senior, hands-on IC
