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Zodiac Solutions, Inc · 2 days ago
Senior REMS Expert
United States
Contract
Remote
Senior Level
12+ years exp
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Hiring Manager
Krishna K.
Insider Connection @Zodiac Solutions, Inc
Responsibilities
Should have sound experience in Risk Evaluation and Mitigation Strategy (REMS).
Hands-on experience in Periodic review reports, RMM tracking with REMS support as per the Regulations and Standards Operating Procedures (SOPs).
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).
Qualification
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Required
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
Preferred
Experience of implementing or using CRM systems such as Salesforce, Dynamics (highly advantageous)
Company
Zodiac Solutions, Inc
“Zodiac Solutions” is a “Minority Business Enterprise” headquartered in Texas, USA.
201-500 employees
H1B Sponsorship
Zodiac Solutions, Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (6)
2020 (1)
Funding
Current Stage
Growth StageRecent News
Project Cargo Journal
2024-05-04
Company data provided by crunchbase
