KrtrimaIQ Cognitive Solutions is a leading organization specializing in clinical research, regulatory documentation, and cognitive technology solutions. With a strong focus on innovation and compliance, we support pharmaceutical and biotech companies in streamlining clinical trial processes. Our expertise spans across ICH-GCP, FDA regulations, and global clinical trial documentation, ensuring high-quality deliverables for our clients.
Job Description: Clinical Trial Document Specialist
Key Responsibilities:
- Draft, review, and perform quality checks (QC) on clinical trial documents, including:
- Protocols
- Clinical Study Reports (CSRs)
- Investigator’s Brochures (IBs)
- New Drug Applications (NDAs)
- Conduct medical and clinical literature reviews to support content development.
- Collaborate with cross-functional teams (Software Engineering, Customer Support, Web Development) to ensure documentation meets regulatory and customer needs.
- Ensure compliance with ICH-GCP, FDA, and global regulatory guidelines.
- Maintain organized documentation using document management systems.
Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field (advanced degree preferred).
- 3+ years of experience in clinical/regulatory documentation (CRO/pharmaceutical background preferred).
- Strong knowledge of ICH-GCP, FDA, EMA, and other regulatory requirements.
- Excellent written and verbal communication skills.
- Detail-oriented with strong analytical and organizational abilities.
Preferred Skills:
- Experience with eCTD submission formats.
- Familiarity with Google Cloud Platform (GCP) for document management.
- Ability to work in a fast-paced, collaborative environment.
Why Join KrtrimaIQ Cognitive Solutions?
✅ Hybrid work model (Bangalore-based)
✅ Opportunity to work on global clinical trials
✅ Collaborative and innovative work culture
✅ Career growth in regulatory and clinical documentation
How to Apply?
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Intrested experienced Candidates Can Send Resume on arun.kumar@krtrimaiq.ai
