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Pharmaceutical Subject Matter Expert (SME) - AI Model Evaluation

11 hours, 59 minutes ago
Indonesia, Vietnam, United States, Philippines, Singapore
Freelance
Mid Level
AI (Artificial Intelligence)
Artificial Intelligence and Machine Learning
LLM
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Volga Partners

Volga Partners

Volga Partners is a technology company that provides innovative solutions and services to clients. With expertise in ML, AI, and crowd management, we deliver high-quality software development, data annotation, content management, data mining, analytics...

Internet Software & Services
51-200
View All Jobs 2

Description

  • Evaluate AI-generated pharmaceutical, scientific, technical, and regulatory content for accuracy, completeness, consistency, and compliance.
  • Review content involving quality systems, manufacturing, validation, regulatory submissions, product development, and compliance.
  • Assess whether AI-generated reasoning is supported by scientific principles, regulatory expectations, and industry best practices.
  • Identify technical inaccuracies, unsupported claims, missing context, inconsistencies, and flawed conclusions.
  • Validate information against FDA requirements, GMP regulations, ICH guidelines, and accepted industry practices.
  • Provide structured feedback, explain findings, and recommend technically accurate corrections.
  • Apply project-specific evaluation criteria, scoring guidelines, and quality standards to support AI improvement.
  • Complete independent evaluations on designated online platforms within project timelines.

Requirements

  • At least 4 years of relevant professional experience in the regulated U.S. pharmaceutical or biotechnology industry.
  • Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Regulatory Affairs, or a related field.
  • Deep expertise in at least one specialty, such as CMC regulatory affairs, quality assurance, technical development, submission writing, analytical development, validation, auditing, or manufacturing/MSAT.
  • Working knowledge of FDA requirements, GMP regulations, and applicable ICH guidelines, including ICH Q7–Q12.
  • Ability to critically assess scientific, technical, and regulatory information and explain technical conclusions.
  • Strong analytical, research, problem-solving, and written English communication skills.
  • Ability to work independently, follow detailed instructions, and meet quality standards using web-based platforms and research tools.
  • Comfort with a task-based freelance engagement in which assignments, hours, and workload may be intermittent.
  • Advanced credentials such as a PharmD or PhD (preferred).
  • Experience with regulatory submissions, FDA-regulated environments, audits, technical writing, content assessment, or AI/LLM evaluation (preferred).

Benefits

  • Project-based hourly compensation of $20–$50 USD per hour, based on specialty, experience, and assignment requirements.
  • Remote work arrangement with assignment-based flexibility.
  • Opportunity to apply pharmaceutical expertise to AI evaluation initiatives.
  • No prior AI experience required.
  • Opportunities for professionals outside the U.S. who have substantial U.S. pharmaceutical industry experience.

Interested in this position?

Apply directly on the company website

Apply Now

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