Engineer clinical document

1 week ago


Gurugram, India Softechera Systems Pvt Ltd Full time

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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