
Document Author and Analyst
2 weeks ago
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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