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Regulatory Specialist

hace 2 meses

Xico, México Syneos - Clinical And Corporate - Prod A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Specialist to join our team at Syneos - Clinical And Corporate - Prod. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and providing high-quality support to our clients.

Key Responsibilities
  • Provide quality assurance on deliverables at the country level and ensure compliance with project requirements and applicable country rules.
  • Work within forecasted submission/approval timelines and track milestone progress in real-time.
  • Monitor basic financial aspects of the project and ensure timely submission of relevant documents to the Trial Master File (TMF).
  • Ensure compliance with Standard Operating Procedures (SOPs) and Work Instructions (WIs) and maintain accurate training records.
Requirements
  • Associate's Degree or equivalent combination of education and training.
  • Good understanding of clinical trial process across Phases II-IV and ICH GCP.
  • Ability to interact effectively and appropriately with investigative site personnel.
  • Good organizational skills and attention to detail.
  • Ability to take direction from multiple individuals and set priorities accordingly.
What We Offer

We offer a dynamic and supportive work environment, opportunities for career growth and development, and a competitive compensation package.