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Senior Clinical Documentation Specialist
3 weeks ago
About Us:
We are a global IT services company headquartered in the United States. Founded in 1996, we specialize in digital engineering and IT services helping clients modernize their technology infrastructure, adopt cloud and AI solutions, and accelerate innovation.
Our company operates in over 50 locations across more than 25 countries, has delivery centers in Asia, Europe, and North America.
Job Title: Clinical Document Authoring
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.
- 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:
- 1-5 years of experience in clinical document authoring.
- Any graduation qualification.
- Hybrid work mode.
- Contract employment type.
Benefits:
- Immediate - 15 days notice period.
- 2 rounds of technical interview.
