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Pharmaceutical Subject Matter Expert (SME) - AI Model Evaluation (USA)

12 hours ago
United States, Canada, United Kingdom, Australia
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 related to quality systems, manufacturing, validation, regulatory submissions, technical development, and compliance.
  • Analyze whether AI-generated conclusions are supported by scientific principles, regulatory expectations, and industry best practices.
  • Identify technical inaccuracies, unsupported claims, missing context, inconsistencies, and flawed reasoning.
  • Validate information against FDA requirements, GMP regulations, ICH guidelines, and accepted industry practices.
  • Provide structured expert feedback and recommend technically accurate corrections.
  • Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
  • Complete independent evaluations through 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, GMP validation, auditing, or manufacturing/MSAT.
  • Working knowledge of FDA requirements, GMP regulations, and relevant ICH guidelines, including applicable ICH Q7–Q12 content.
  • Ability to critically evaluate complex scientific, technical, and regulatory information independently.
  • Strong analytical, research, problem-solving, and written English communication skills.
  • Ability to explain technical conclusions clearly, follow detailed instructions, and meet quality standards.
  • Comfort using digital platforms, web-based applications, and online research tools.
  • Comfort with a variable, task-based freelance engagement model.
  • Advanced credentials, regulatory submission experience, FDA-regulated environment experience, auditing or technical writing experience, and AI/LLM evaluation familiarity are preferred.

Benefits

  • Project-based hourly compensation of $20–$50 USD per hour, based on specialty, experience, location, and assignment complexity.
  • Remote work from the United States, with consideration for international professionals who have substantial U.S. industry experience.
  • Flexible, assignment-based schedule suitable for supplemental income.
  • Opportunity to contribute pharmaceutical expertise to AI evaluation projects without prior AI experience.

Interested in this position?

Apply directly on the company website

Apply Now

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