SeniorREMS Expert

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Role : Senior REMS Expert

Location : Raleigh NC (Hybrid 23 days from office)

Hire Type : Contract

Indent : PSL

Year of exp : 12

Job Description :

Around 12 Years experience in healthcare domain

Should have sound experience in Risk Evaluation and Mitigation Strategy (REMS).

Handson experience in Periodic review reports RMM tracking with REMS support as per the Regulations and Standards Operating Procedures (SOPs)

A deep knowledge of Drug safety FDA REMS program requirements and key processes.

Experience in design and implementation of REMS systems and tools.

Good understanding of SDLC requirements and 21 CFR Part 11 GxP guidelines

Prior experience of participating in designing and implementing REMS systems

Experience of implementing or using CRM systems such as Salesforce Dynamics (highly advantageous)