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Regulatory Content Creator

1 week ago

Cork, Cork, Ireland Tata Consultancy Services Full time

We are looking for an experienced Regulatory Content Creator to join our team at Tata Consultancy Services. As a Regulatory Content Creator, you will be responsible for creating high-quality, scientifically accurate, and compliant content to meet client briefs.

The ideal candidate will have a strong background in medical writing within the clinical research/pharmaceutical industry, with a focus on Phase 1 and Phase 2 clinical trials. They will possess a deep understanding of ICH GCP guidelines, regulatory requirements, and compliance standards set by relevant agencies (e.g., FDA, EMA).

Responsibilities:
  • Content Creation:
    • Develop comprehensive and scientifically rigorous protocols that align with regulatory and ethical standards.
    • Author, review, and finalise high-quality clinical trial documents, including study protocols and protocol amendments.
    • Create and update initial investigator's brochures (IBs) to ensure they reflect the most current clinical and non-clinical data.
  • Regulatory Compliance:
    • Ensure all documents comply with ICH GCP, regulatory requirements, and internal SOPs.
    • Conduct thorough quality checks to ensure accuracy, consistency, and completeness of data and content.