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Document Authoring Specialist
3 weeks ago
About Us:
We are a global company that partners with major firms in healthcare, telecom, and media. Our team combines deep industry expertise with agile development practices to enable scalable and cost-effective digital transformation.
The position is for a Clinical Document Authoring Specialist who will work on clinical trial documents.
Key Responsibilities:
- Author and analyze clinical trial documents.
- Work with key clinical documents such as 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.