
Research Document Specialist
4 days ago
About our Clinical Document Authoring opportunity:
We are seeking a highly skilled professional to join our team in authoring and analyzing clinical trial documents.
The ideal candidate will have expertise in creating, validating, and refining prompts for AI-assisted document generation, as well as knowledge of clinical trial phases, study design, and drug development.
Key Responsibilities include:
- 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.
- Apply knowledge of medical terminologies and ontologies for clarity and consistency.
Our team is known for combining deep industry expertise with agile development practices, enabling scalable and cost-effective digital transformation.
Required Skills and Qualifications:
- Protocol
- Informed Consent Form (ICF)
- Knowledge of FDA, EMA, and ICH-GCP guidelines
Benefits of this role include the opportunity to work collaboratively with cross-functional teams, ensuring quality control and timely delivery of assigned tasks.
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