Pharmaceutical Subject Matter Expert – AI Model Evaluation

This is a fully remote position, open to applicants in United States.

📋 Description

• Assess AI-generated pharmaceutical content for accuracy, thoroughness, consistency, and adherence to industry standards.

• Examine scientific and regulatory information pertinent to quality systems, manufacturing, validation, submissions, development, and compliance.

• Evaluate whether AI-generated conclusions are substantiated by scientific principles, regulatory expectations, and industry best practices.

• Detect unsupported claims, technical inaccuracies, omitted context, and flawed reasoning.

• Validate information in accordance with FDA requirements, GMP regulations, ICH guidelines, and accepted practices in the pharmaceutical industry.

• Offer professional feedback, clarify findings, pinpoint enhancements, and suggest technically accurate corrections.

• Utilize project-specific evaluation criteria, scoring frameworks, and quality standards to facilitate improvements in AI quality.

• Conduct independent evaluations using designated online platforms accurately and within project deadlines.

⛳️ Requirements

• At least four years of relevant professional experience in the regulated pharmaceutical or biotechnology sectors.

• A bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Regulatory Affairs, or a related field.

• Strong expertise in at least one of the pharmaceutical specialties listed.

• Proficient understanding of FDA requirements, GMP regulations, and relevant ICH guidelines, including applicable sections of ICH Q7-Q12.

• Capability to critically assess scientific, technical, and regulatory information.

• Strong analytical, research, and problem-solving skills.

• Excellent proficiency in written English communication.

• Confidence in reviewing complex information and articulating technical conclusions.

• Proficiency with digital platforms, web-based applications, and online research tools.

• Ability to work independently while adhering to detailed instructions and established quality standards.

• Understanding of and comfort with a task-based freelance engagement model.

• Preferred: PharmD, PhD, or other advanced scientific qualifications.

• Preferred: Experience in preparing or reviewing regulatory submissions (IND, NDA, BLA, ANDA, MAA, or equivalent).

• Preferred: Experience in FDA-regulated manufacturing, quality, compliance, validation, or development settings.

• Preferred: Experience conducting quality reviews, regulatory audits, or scientific content evaluations.

• Preferred: Background in technical writing, structured reviews, or compliance assessments.

• Preferred: Familiarity with AI model evaluation, prompt review, rubric development, or data annotation.

• Preferred: Previous participation in scientific, regulatory, quality, or technical content assessment activities.

🏝️ Benefits

• Remote work from an eligible location.

• Flexible, assignment-based schedule.

• Project-based freelance opportunities.

• Chance to contribute to cutting-edge AI technologies.

• Experience in AI evaluation initiatives.

• No background in AI is required.

• Hourly compensation based on specialization, experience, qualifications, geographic location, and project demands.