Expert Clinical Documentation Specialist

2 days ago


Mumbai, Maharashtra, India beBeeClinical Full time ₹ 21,90,000 - ₹ 2,43,10,000
Job Description:

As a Clinical Document Authoring specialist, you will be responsible for crafting and analyzing clinical trial documents. Your expertise will ensure the accuracy and clarity of these critical documents.

The ideal candidate will have in-depth knowledge of clinical trial phases, study design, and drug development. You will work with key clinical documents such as protocols, informed consent forms, clinical study reports, and more.

  • Create, validate, and refine prompts for AI-assisted document generation
  • Apply medical terminologies and ontologies for consistency and clarity
  • Ensure quality control and timely delivery of assigned tasks
Key Responsibilities:
  • Author and analyze clinical trial documents
  • Work with cross-functional teams to improve document accuracy and prompt effectiveness
  • Collaborate with project managers to provide regular updates and flag risks
Requirements:
  • Experience with clinical trial documentation and regulations (FDA, EMA, ICH-GCP)
  • Strong understanding of medical terminologies and ontologies
  • Excellent communication and collaboration skills
Benefits:

This is a contract position with a hybrid work model. The employment type is contract, and the notice period is immediate - 15 days. Interviews will consist of two rounds of technical interviews.



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