Consultant – Clinical SME / Medical Reviewer
Location: Gurugram
Experience: 8–10 Years
Key Skills: Medical Review, Clinical Research, Medical Affairs, Clinical Operations, Clinical Documentation, Clinical Protocols, SOPs, GCP, Regulatory Compliance, Quality Assurance, AI/LLM Validation, UAT, Medical Content Governance, Process Improvement
Role Overview
We are seeking a Consultant – Clinical SME / Medical Reviewer with 8–10 years of experience in medical review, clinical research, clinical operations, medical affairs, or related life sciences domains.
The role will provide senior-level clinical subject matter expertise for AI/LLM-enabled medical review and knowledge management initiatives. The candidate will lead medical validation activities, assess the accuracy and quality of AI-generated outputs, establish and improve review frameworks, and work closely with technical and cross-functional teams to address recurring extraction, classification, and reasoning issues.
Roles & Responsibilities
- Lead the medical review and validation of information generated through LLM-based extraction pipelines and chatbot workflows.
- Evaluate AI-generated outputs for clinical accuracy, completeness, consistency, source alignment, and compliance.
- Validate complex chatbot responses against approved CSRs, clinical protocols, SOPs, scientific literature, prescribing information, and medical/regulatory documentation.
- Identify recurring extraction, classification, reasoning, and content-quality issues and work with AI/technical teams to determine appropriate improvements.
- Define, maintain, and continuously enhance medical review workflows, validation frameworks, quality standards, and review methodologies.
- Lead or provide senior SME support for UAT activities, including assessment of system performance against clinical quality and accuracy measures.
- Drive quality assurance activities and ensure consistent application of medical review and governance standards.
- Review complex or ambiguous clinical content and provide expert interpretation and resolution.
- Partner with cross-functional stakeholders to improve AI-assisted medical review processes and knowledge management practices.
- Provide senior clinical SME guidance on governance, compliance, and regulatory considerations throughout the review lifecycle.
Qualification & Expertise:
Essential:
- 8–10 years of experience in Medical Review, Clinical Research, Clinical Operations, Medical Affairs, or related life sciences domains.
- Proven experience leading or owning medical review and quality assurance activities.
- Strong expertise in interpreting and validating complex clinical and scientific information.
- Strong knowledge of:
o Clinical protocols
o SOPs
o GCP guidelines
o Clinical Study Reports (CSRs)
o Scientific literature
o Prescribing information
o Medical and regulatory documentation
- Experience driving process improvements and quality initiatives.
- Strong experience working with cross-functional stakeholders.
- Ability to establish or improve review and validation frameworks.
Preferred:
- Experience with AI-assisted medical review workflows.
- Practical familiarity with Generative AI and Large Language Models (LLMs).
- Experience evaluating AI-generated clinical/medical outputs.
- Exposure to chatbot validation, knowledge management systems, or intelligent document processing.
Understanding of clinical quality metrics and AI/model 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 clinical judgment and critical-thinking ability.
- Excellent analytical and problem-solving skills.
- Strong ownership of medical quality and review outcomes.
- Ability to lead review activities and influence quality improvements.
- Strong stakeholder-management and cross-functional collaboration skills.
- Excellent written and verbal communication.
- Ability to explain complex clinical issues clearly to technical and non-technical stakeholders.
- Strong decision-making skills when handling ambiguous or complex medical information.
- Ability to mentor or guide junior team members on medical review and quality practices.
Apply Now
Interested candidates can apply at: [email protected]
Work Location: In person
