Pharmaceutical Subject Matter Expert – AI Model Evaluation

This is a fully remote position, open to applicants in United States, +4 more countries.

📋 Description

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

• Examine scientific and regulatory data related to quality systems, manufacturing, validation, submissions, development, and compliance.

• Evaluate whether conclusions drawn by AI are substantiated by scientific principles, regulatory requirements, and industry best practices.

• Detect unsupported assertions, technical errors, lack of context, and faulty reasoning.

• Utilize FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices to verify information.

• Offer expert insights, clarify findings, and suggest technically accurate corrections.

• Implement project-specific evaluation criteria, scoring methodologies, and quality standards to enhance AI quality.

• Conduct independent assessments using designated online platforms within the defined project timelines.

⛳️ Requirements

• A minimum of four years of pertinent professional experience in the regulated pharmaceutical or biotechnology sector based in the US.

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

• Strong proficiency in at least one of the specified pharmaceutical specialties.

• Familiarity with FDA guidelines, GMP regulations, and relevant ICH directives, including applicable sections of ICH Q7-Q12.

• Ability to critically analyze scientific, technical, and regulatory information.

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

• Excellent written communication skills in English.

• Confidence in reviewing complex information and articulating technical conclusions.

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

• Capability to work independently, adhere to detailed instructions, and meet established quality benchmarks.

• Must be comfortable 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 similar).

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

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

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

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

🏝️ Benefits

• Opportunity for remote work.

• Flexible, variable, assignment-based schedule.

• Project-based freelance opportunities.

• Chance to contribute to cutting-edge AI technologies.

• Additional income potential.

• No background in AI is necessary.