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Senior REMS Specialist

3 months ago

Leigh, Wigan, United Kingdom Intone Networks Inc Full time

Position Overview:

We are seeking a qualified candidate for the role of Senior REMS Specialist at Intone Networks Inc.

Location: This position offers a hybrid work model.

Contract Type: This is a contract-based role.

Experience Required: A minimum of 12 years in the healthcare sector.

Key Responsibilities:

  • Possess extensive experience in Risk Evaluation and Mitigation Strategy (REMS).
  • Demonstrate hands-on expertise in generating periodic review reports and managing RMM tracking in accordance with regulatory standards and operating procedures.
  • Exhibit a profound understanding of drug safety requirements as mandated by the FDA's REMS program.
  • Engage in the design and execution of REMS systems and associated tools.
  • Showcase a solid grasp of Software Development Life Cycle (SDLC) requirements and compliance with 21 CFR Part 11 GxP guidelines.
  • Have prior involvement in the architecture and implementation of REMS systems.
  • Experience with CRM systems such as Salesforce Dynamics is highly advantageous.

Qualifications:

The ideal candidate will bring a wealth of knowledge and practical experience in the REMS domain, contributing to the safety and efficacy of healthcare solutions.