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Medical Director/Sr Medical Director - Rheumatology

Thermo Fisher Scientific

Thermo Fisher Scientific seeks a Medical Director or Senior Medical Director in Rheumatology to provide medical oversight of clinical trials, ensure regulatory compliance, and support safety monitoring and reporting. The role involves clinical trial management, adverse event review, and collaboration with investigators and clients across a global portfolio.

Responsibilities

  • Oversee clinical trial safety variables including adverse events, lab abnormalities, and protocol compliance monitoring
  • Review and medically interpret serious adverse events, clinical outcomes, and periodic safety reports
  • Provide medical consultation to investigators, clients, and project team members on study-related questions
  • Review and contribute to regulatory documents including CSR, IND/NDA reports, RMP, and REMS
  • Manage signal detection activities and support risk management for marketed products

Requirements

  • MD or equivalent medical degree; active medical licensure preferred
  • Clinical experience treating patients in rheumatology or related specialty (approximately 2 years)
  • Clinical trial experience in CRO, pharmaceutical company, or as principal investigator (1-2 years)
  • Direct safety or pharmacovigilance experience (approximately 2 years)
  • Therapeutic expertise in rheumatology or relevant medical specialty
  • Working knowledge of safety databases such as MedDRA
  • Strong written and oral communication skills
Vacante publicada el 13 días atrás
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