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Senior REMS Specialist
3 months ago
Position Overview:
We are seeking a highly skilled Senior REMS Specialist to join our team at Intone Networks Inc. This role requires extensive experience in the healthcare sector, particularly in Risk Evaluation and Mitigation Strategies (REMS).
Location: Hybrid role with a combination of remote work and in-office presence.
Contract Type: Contractual engagement.
Experience Required: Minimum of 12 years in the healthcare domain.
Key Responsibilities:
- Demonstrate profound expertise in Risk Evaluation and Mitigation Strategies (REMS).
- Provide hands-on support in the preparation of periodic review reports and Risk Management Monitoring (RMM) tracking in compliance with regulatory standards.
- Possess in-depth knowledge of FDA REMS program requirements and associated processes.
- Lead the design and implementation of REMS systems and tools.
- Understand Software Development Life Cycle (SDLC) requirements and adhere to 21 CFR Part 11 GxP guidelines.
- Participate actively in the design and execution of REMS systems.
- Utilize or implement Customer Relationship Management (CRM) systems, with a preference for Salesforce Dynamics.
This position offers an opportunity to leverage your expertise in a dynamic environment, contributing to the advancement of healthcare safety and compliance.
