Regulatory Affairs Specialist

3 days ago


Fatih, Istanbul, Turkey IQVIA Full time

Job Description

We are seeking a Regulatory Affairs Specialist to join our team. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and developing and executing comprehensive contracting strategies for our clients.

Responsibilities

  • Ensure compliance with GCP/ICH and applicable regulatory guidelines.
  • Develop and coordinate the development of investigator grants and estimates, contracting strategies, and proposal text to support the proposal development process.
  • Develop contract language, payment language, and budget templates as required and applicable to the position.
  • Maintain and utilize contracting systems, tools, processes, and training materials for selected sponsors, studies, or multi-protocol programs according to the Scope of Work and Project Plan.

Requirements

  • Bachelor's Degree in a related field is required; 5 years of relevant sponsor or clinical research organization clinical site contracting experience, including global and/or regional experience acting as a contract negotiator.
  • Knowledge of applicable regulatory requirements, SOPs, and company Corporate Standards.


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