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Role : Senior REMS Expert
Location : Raleigh NC (Hybrid 23 days from office)
Hire Type : Long Term Contract
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)
Best Regards
Avneesh Shukla
Siri InfoSolutions Inc 3 Ethel Rd Suite # 302 Edison NJ 08817.
CPUC Certified
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Full Time