Associate Engineer/ Engineer / Senior Engineer

Company Overview

Company details are not specified.

Job Summary

The Associate Engineer/ Engineer/ Senior Engineer role focuses on the authoring and analyzing of clinical trial documents. This position is integral to ensuring that documentation meets global regulatory standards and supports the broader goals of clinical research and drug development.

Responsibilities

• Author and analyze clinical trial documents.
• Work with key clinical documents, including:
  • Protocol
  • Informed Consent Form
  • Clinical Study Report
  • Summary of Clinical Safety/Efficacy
  • Access Evidence Dossier
  • Statistical Analysis Plan and more.
• 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).
• Utilize medical terminologies and ontologies for clarity and consistency.
• Ensure quality control and timely delivery of assigned tasks.
• Collaborate with cross-functional teams to improve document accuracy and prompt effectiveness.
• Provide regular updates and flag risks to the project manager.

Qualifications

• Mandatory Skills: Clinical document authoring.
• Solid understanding of clinical trial phases and drug development processes.
• Familiarity with regulatory standards and guidelines, including FDA, EMA, and ICH-GCP.
• Proficient use of medical terminologies and ontologies.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication abilities.
• Attention to detail and commitment to quality.

Preferred Skills

• Experience with AI-assisted document generation tools.
• Knowledge of statistical analysis related to clinical trials.

Experience

• 1-5 years of relevant experience in clinical document authoring and analysis is preferred.

Environment

• Location options include Bangalore or Gurgaon. Details regarding the work setting (remote, in-office, hybrid) are not specified.

Salary

Salary details are not provided.

Growth Opportunities

Career advancement opportunities are not specified.

Benefits

Benefits offered are not specified.