Are you an experienced clinical or regulatory documentation professional passionate about ensuring the quality and compliance of clinical trial materials? KrtrimaIQ Cognitive Solutions, a leading innovator in clinical research and cognitive technology, invites you to join their Bangalore team as a Regulatory Clinical Trial Document Specialist.
This role offers a unique opportunity to work on global clinical trials in a dynamic, hybrid environment while applying your expertise in regulatory guidelines and clinical documentation standards.
About KrtrimaIQ Cognitive Solutions
KrtrimaIQ Cognitive Solutions specializes in clinical research services, regulatory documentation, and leveraging cognitive technologies to streamline clinical trial processes for pharmaceutical and biotech companies. The organization is committed to quality, compliance, and innovation, helping clients navigate the complex regulatory landscape including ICH-GCP, FDA, and EMA requirements.
Position Overview
As a Regulatory Clinical Trial Document Specialist, you will play a pivotal role in drafting, reviewing, and quality-checking vital clinical trial documents, ensuring they meet stringent regulatory standards. Your work will directly support the submission and approval processes for clinical studies worldwide.
Job Location
Bangalore, India (Hybrid Work Model)
Eligibility Criteria
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field
- Minimum 3 years of experience in clinical or regulatory documentation within pharmaceutical or CRO settings
- Strong understanding of ICH-GCP, FDA, EMA, and other relevant global regulations
Key Responsibilities
Your daily tasks will include:
- Drafting and reviewing essential clinical trial documents such as Protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and New Drug Applications (NDAs)
- Performing rigorous quality control checks to ensure accuracy, completeness, and compliance with regulatory guidelines
- Conducting medical and clinical literature reviews to support content development and validation
- Collaborating effectively with cross-functional teams, including software engineers, customer support, and web development, to align documentation with project and customer needs
- Maintaining organized, accessible documentation within document management systems such as Google Cloud Platform (GCP)
- Ensuring all documentation complies with global standards like ICH-GCP, FDA, and other regulatory bodies
Desired Skills and Competencies
To succeed in this role, you should demonstrate:
- Exceptional written and verbal communication skills tailored to scientific and regulatory contexts
- Keen attention to detail with strong analytical and organizational capabilities
- Experience with eCTD (electronic Common Technical Document) submission formats is an advantage
- Ability to thrive in a fast-paced, collaborative, and innovative work environment
Why Work at KrtrimaIQ?
- Benefit from a hybrid work model that offers flexibility without compromising collaboration
- Engage with global clinical trials that expand your regulatory and documentation expertise
- Join a forward-thinking organization driven by innovation and teamwork
- Experience clear career growth opportunities in the niche areas of regulatory and clinical documentation
The Significance of Clinical Trial Documentation
Clinical trial documents are the backbone of drug development and regulatory approval. Quality, clarity, and compliance in these documents ensure that clinical studies are conducted ethically and scientifically, protecting patient safety and advancing medical knowledge.
At KrtrimaIQ, your role ensures the integrity and accuracy of these documents, directly influencing the success of clinical trials and subsequent drug approvals worldwide.
How to Apply
Interested candidates with the required experience and qualifications can apply by sending their updated resume to the recruitment email provided by KrtrimaIQ. Prepare to highlight your expertise in regulatory documentation and your knowledge of compliance frameworks.
Conclusion
For professionals with a background in life sciences and a passion for clinical research documentation, the Regulatory Clinical Trial Document Specialist role at KrtrimaIQ offers a stimulating and rewarding career path.
Join KrtrimaIQ Cognitive Solutions and contribute to the future of clinical research by ensuring that essential trial documents meet the highest standards of quality and regulatory compliance.
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