Research Document Author

6 days ago

Pune, Maharashtra, India beBeeClinical Full time ₹ 1,80,00,000 - ₹ 2,40,00,000
Job Description

As a key member of our team, you will be responsible for authoring and analyzing clinical trial documents.

The ideal candidate will have experience working with key clinical documents such as protocols, informed consent forms, clinical study reports, and statistical analysis plans.

You will create, validate, and refine prompts for AI-assisted document generation while maintaining compliance with global regulatory standards.

A strong understanding of clinical trial phases, study design, and drug development is essential for this role.

You will also utilize medical terminologies and ontologies to ensure clarity and consistency in your work.

Additionally, you will collaborate with cross-functional teams to improve document accuracy and prompt effectiveness.

Our team is committed to delivering high-quality results, and we are looking for someone who shares this vision.

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 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.
Requirements:
  • Experience with clinical trial documentation and AI-assisted document generation.
  • Strong understanding of clinical trial phases, study design, and drug development.
  • Ability to work with cross-functional teams to improve document accuracy and prompt effectiveness.
  • Excellent communication and project management skills.
  • Ability to maintain compliance with global regulatory standards (FDA, EMA, ICH-GCP).
  • Experience with medical terminologies and ontologies.
Benefits:

As a valued member of our team, you will enjoy a range of benefits including:

  • Competitive salary.
  • Bonuses and incentives.
  • Opportunities for career growth and development.
  • A collaborative and dynamic work environment.
Others:

Interested candidates please share your CV to us.

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