Engineer clinical document
3 days ago
Associate Engineer/Engineer/Senior Engineer - 1-5 years
Process for selection: An aptitude test and interview
Location - Bengaluru/Gurgaon (Hybrid)
Contract Period -
6 months (can be extended based on demand and performance of the employee)
Must have skill:
- We need people with core clinical document authoring background for documents like - Protocol, Informed Consent Form, Clinical Study Report, Summary of Clinical Safety/Efficacy, Access Evidence Dossier, Statistical Analysis Plan, Investigator's Brochure
- Overall knowledge of drug development process, clinical trials, Regulatory FDA and EMA and ICH-GCP
- Understanding of common medical terminologies and ontologies
Good to have skills:
- Experience of leveraging GenAI tools (like ChatGPT)
- Prompt writing and validation
-
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