Regulatory Document Writer

1 week ago


Cork, Cork, Ireland eir evo talent Full time
About the Role

eir evo talent is currently looking for a highly skilled Regulatory Document Writer to join our team. As a Regulatory Document Writer, you will be responsible for ensuring that all clinical trial documents comply with ICH GCP, regulatory requirements, and internal SOPs.

Key Responsibilities:
  • Conduct thorough quality checks to ensure accuracy, consistency, and completeness of data and content.
  • Review and interpret clinical data to ensure accuracy and consistency in documentation, aligning with study objectives and regulatory expectations.
Requirements:
  • Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field.
  • Strong experience in medical writing within the clinical research industry, with a focus on Phase 1 and Phase 2 clinical trials.
  • Proven track record of authoring and managing regulatory documents such as study protocols, IBs, and CSRs.


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