Associate Consultant – Clinical SME / Medical Reviewer
Location: Gurugram
Experience: 4–6 Years
Key Skills: Medical Review, Clinical Research, Clinical Operations, Clinical Documentation, Clinical Protocols, SOPs, GCP, Regulatory Compliance, Clinical Study Reports, Scientific Literature, Medical Writing, AI/LLM Output Validation, UAT
Role Overview
We are seeking an Associate Consultant – Clinical SME / Medical Reviewer with 4–6 years of experience in clinical research, medical review, clinical operations, pharmacovigilance, medical writing, or related life sciences functions.
The role will focus on reviewing and validating information generated through AI/LLM-based extraction pipelines and chatbot workflows. The candidate will ensure that AI-generated medical information is clinically accurate, complete, consistent with approved source documents, and aligned with applicable quality and regulatory requirements.
Roles & Responsibilities
- Review and validate information extracted through LLM-based extraction pipelines for clinical accuracy, completeness, and consistency.
- Identify and correct extraction errors, ambiguities, inconsistencies, and content gaps.
- Validate chatbot-generated responses against clinical protocols, SOPs, CSRs, prescribing information, scientific literature, and approved medical sources.
- Review clinical and scientific documentation to ensure accuracy and adherence to defined quality standards.
- Apply established medical review and validation frameworks to assess AI-generated outputs.
- Support User Acceptance Testing (UAT) by reviewing system outputs and documenting clinical observations and defects.
- Analyze recurring extraction and classification issues and provide structured feedback to technical/AI teams.
- Support continuous improvement of medical review workflows, validation processes, and quality standards.
- Ensure reviewed content follows organizational governance, compliance, and applicable regulatory requirements.
- Provide clinical subject matter expertise for AI-enabled medical review and knowledge management initiatives.
Qualification & Expertise:
Essential:
- 4–6 years of experience in Medical Review, Clinical Research, Clinical Operations, Pharmacovigilance, Medical Writing, or related life sciences functions.
- Strong understanding of clinical protocols, SOPs, GCP guidelines, and regulatory requirements.
- Experience reviewing clinical and scientific documentation.
- Experience with one or more of the following:
o Clinical Study Reports (CSRs)
o Clinical Protocols
o SOPs
o Scientific Literature
o Prescribing Information
o Medical and Regulatory Documentation
- Strong understanding of healthcare and life sciences information.
- Experience with quality review and validation activities.
Preferred:
- Exposure to Generative AI and Large Language Models (LLMs).
- Experience evaluating AI-generated medical or scientific content.
- Exposure to chatbot validation or knowledge management systems.
- Understanding of clinical quality metrics or AI output evaluation frameworks.
Educational Qualification:
To be confirmed based on organizational requirements. Relevant qualification in life sciences, clinical, medical, or related discipline is aligned with the role.
Soft Skills & Leadership:
- Strong analytical and critical-thinking ability.
- High attention to detail and commitment to content accuracy.
- Ability to identify inconsistencies, gaps, and potential compliance risks.
- Clear written and verbal communication.
- Ability to provide structured and actionable review feedback.
- Good collaboration skills with clinical and technical teams.
- Ability to work independently and manage review activities within defined timelines.
- Willingness to learn and adapt to AI-enabled medical review processes.
Apply Now
Work Location: In person
