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Senior REMS Expert

2 months ago

Leigh, Wigan, United Kingdom Intone Networks Inc Full time

About Intone Networks Inc

We are seeking a highly experienced Senior REMS Expert to join our team at Intone Networks Inc. As a Senior REMS Expert, you will play a critical role in ensuring the safe and effective management of risk evaluation and mitigation strategies (REMS) in the healthcare domain.

Key Responsibilities

  • Develop and implement REMS systems and tools to ensure compliance with regulations and standards.
  • Collaborate with cross-functional teams to design and implement REMS systems that meet business requirements.
  • Provide subject matter expertise on REMS program requirements, including FDA regulations and 21 CFR Part 11 GxP guidelines.
  • Participate in the development of business cases and proposals for REMS-related projects.
  • Stay up-to-date with industry trends and developments in REMS and healthcare domain.

Requirements

  • 12+ years of experience in the healthcare domain, with a strong focus on REMS.
  • Proven experience in risk evaluation and mitigation strategy (REMS) development and implementation.
  • Hands-on experience with periodic review reports, RMM tracking, and REMS support.
  • Deep knowledge of drug safety, FDA REMS program requirements, and key processes.
  • Experience with CRM systems such as Salesforce Dynamics (highly advantageous).

What We Offer

At Intone Networks Inc, we offer a dynamic and challenging work environment that fosters growth and development. As a Senior REMS Expert, you will have the opportunity to work with a talented team of professionals who are passionate about delivering high-quality solutions.