
Clinical Document Authoring Specialist
2 days ago
We are seeking a skilled Clinical Document Authoring Specialist to join our team. This role involves the creation, analysis, and refinement of clinical trial documents, including protocols, informed consent forms, and clinical study reports.
Key Responsibilities:
- Author and analyze clinical trial documents, including protocols, informed consent forms, and clinical study reports.
- Work with key clinical documents and create, validate, and refine prompts for AI-assisted document generation.
- Apply knowledge of clinical trial phases, study design, and drug development to ensure compliance with global regulatory standards (FDA, EMA, ICH-GCP).
- Utilize medical terminologies and ontologies for clarity and consistency and maintain quality control and timely delivery of assigned tasks.
About this Opportunity:
This is an excellent opportunity for individuals who possess strong analytical and writing skills, as well as experience in clinical research and document authoring. We offer a dynamic and collaborative work environment that fosters professional growth and development.
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