
Document Authoring Specialist
3 days ago
About Us:
We are a global organization with extensive experience in clinical document authoring. We work with various stakeholders to create high-quality documents for clinical trials.
Our team of experts collaborates to analyze and create documents such as protocols, informed consent forms, clinical study reports, and more.
The successful candidate will have knowledge of clinical trial phases, study design, and drug development. They will also be familiar with regulatory standards like FDA, EMA, and ICH-GCP.
Key Responsibilities:
- Analyze and create clinical trial documents
- Collaborate with cross-functional teams to ensure document accuracy
- Apply knowledge of clinical trial phases and regulatory standards
- Utilize medical terminologies and ontologies for clarity and consistency
Required Skills:
- Protocol
- Informed Consent Form (ICF)
- FDA
- EMA
- ICH-GCP
Benefits:
- Hybrid work mode
- Contract employment type
- Immediate - 15 Days notice period
Experience Required: 1-5 Years
Education Qualification: Any Graduation
Interview Mode: 2 Rounds of Technical Interview
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