Document Author and Analyst

2 weeks ago


Varanasi, Uttar Pradesh, India beBeeClinical Full time ₹ 8,00,000 - ₹ 15,00,000

About Our Client:

We are a global IT services company with headquarters in the United States. Founded in 1996, we specialize in digital engineering and provide IT services to clients worldwide. We operate in over 50 locations across more than 25 countries, have delivery centers in Asia, Europe, and North America.

Job Title: Clinical Document Authoring

Key Responsibilities:

  • Author and analyze clinical trial documents.
  • Work with key clinical documents: Protocol, Informed Consent Form, Clinical Study Report, Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan.
  • Create, validate, and refine prompts for AI-assisted document generation.
  • Apply knowledge of clinical trial phases, study design, and drug development.
  • Maintain compliance with global regulatory standards (FDA, EMA, ICH-GCP).

Skills:

  • Protocol
  • Informed Consent Form (ICF)
  • FDA
  • EMA
  • ICH-GCP

Experience: 1 -5 Years

Education Qualification: Any Graduation

Work Mode: Hybrid

Employment Type: Contract

Interview Mode: 2 Rounds of Technical Interview



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