Pharmaceutical Subject Matter Expert – AI Model Evaluation

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

📋 Description

• Assess the accuracy, completeness, consistency, and adherence to industry standards of AI-generated pharmaceutical content.

• Examine scientific and regulatory data related 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, lack of context, and flawed reasoning.

• Verify information against FDA requirements, GMP regulations, ICH guidelines, and established pharmaceutical industry practices.

• Offer expert feedback, clarify findings, pinpoint areas for improvement, and suggest technically accurate corrections.

• Implement project-specific evaluation criteria, scoring guidelines, and quality standards.

• Conduct independent evaluations using designated online platforms within the specified project timelines.

⛳️ Requirements

• A minimum of four years of pertinent professional experience in the regulated pharmaceutical or biotechnology sector 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 pharmaceutical specialty: CMC Regulatory Affairs; Pharmaceutical Quality Assurance; CMC Science / Technical Development; Regulatory CMC Submission Writing; Quality Control / Analytical Development; GMP Compliance / Validation; Regulatory Compliance Auditing; or Pharmaceutical Manufacturing / MSAT.

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

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

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

• Excellent written communication skills in English.

• Confidence in reviewing complex information and articulating technical conclusions.

• Proficient in utilizing digital platforms, web-based applications, and online research tools.

• Ability to work autonomously, adhere to detailed instructions, and meet established quality standards.

• Must be familiar with and comfortable operating within a task-based freelance engagement model.

• PharmD, PhD, or advanced scientific credentials are preferred.

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

• Experience in FDA-regulated manufacturing, quality, compliance, validation, or development environments is preferred.

• Background in performing quality reviews, regulatory audits, or scientific content evaluations is preferred.

• Experience in technical writing, structured reviews, or compliance assessments is preferred.

• Familiarity with AI model evaluation, prompt review, rubric development, or data annotation is preferred.

• Previous engagement in scientific, regulatory, quality, or technical content assessment activities is preferred.

🏝️ Benefits

• Opportunity to work remotely from an eligible location.

• Flexible and variable assignment-based schedule.

• Project-based assignments.

• Chance to contribute to cutting-edge AI technologies.

• Opportunity to enhance the scientific accuracy of AI-generated pharmaceutical information.

• Experience participating in AI evaluation initiatives.

• Supplemental-income freelance engagement.