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Pharmaceutical Subject Matter Expert – AI Model Evaluation
Volga Partners. Evaluate AI-generated pharmaceutical content for accuracy, completeness, consistency, and compliance with industry standards .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in evaluating AI-generated pharmaceutical content for accuracy and compliance with FDA requirements, GMP regulations, and ICH guidelines. Possesses strong analytical and problem-solving skills, with the ability to provide expert feedback and recommendations for improvement.
Highest-signal resume keywords
Pharmaceutical Content EvaluationFDA Requirements KnowledgeGMP Regulations FamiliarityAnalytical SkillsTechnical Writing Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Pharmaceutical SciencesRegulatory AffairsQuality Systems AnalysisScientific EvaluationAI Model EvaluationData AnnotationRegulatory Submissions PreparationValidation ProcessesCompliance AssessmentsResearch Methodologies
Soft Skills
Excellent Written CommunicationProblem-Solving AbilitiesIndependent Work CapabilityAttention to DetailConfidence in Reviewing Complex Information
Tools & Technologies
Digital PlatformsWeb-Based ApplicationsOnline Research Tools
Certifications & Qualifications
PharmDPhDAdvanced Scientific Credentials
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryICH GuidelinesQuality ImprovementRegulatory ComplianceScientific Content AssessmentTechnical ReviewsFreelance Engagement Model
About the role
Key responsibilities & impact- Evaluate AI-generated pharmaceutical content for accuracy, completeness, consistency, and compliance with industry standards
- Review scientific and regulatory information related to quality systems, manufacturing, validation, submissions, development, and compliance
- Analyze whether AI-generated conclusions are supported by scientific principles, regulatory expectations, and industry best practices
- Identify unsupported claims, technical inaccuracies, missing context, and flawed reasoning
- Validate information using FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices
- Provide expert feedback, explain findings, identify improvements, and recommend technically accurate corrections
- Apply project-specific evaluation criteria, scoring guidelines, and quality standards to support AI quality improvement
- Complete independent evaluations using designated online platforms accurately and within project timelines
Requirements
What you’ll need- Minimum of four years of relevant professional experience in the regulated pharmaceutical or biotechnology industry
- Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Regulatory Affairs, or a related discipline
- Strong expertise in at least one listed pharmaceutical specialty
- Working knowledge of FDA requirements, GMP regulations, and relevant ICH guidelines, including applicable portions of ICH Q7-Q12
- Ability to critically evaluate scientific, technical, and regulatory information
- Strong analytical, research, and problem-solving abilities
- Excellent written English communication skills
- Confidence reviewing complex information and explaining technical conclusions
- Comfort using digital platforms, web-based applications, and online research tools
- Ability to work independently, follow detailed instructions, and meet established quality standards
- Understanding of and comfort with a task-based freelance engagement model
- Preferred: PharmD, PhD, or advanced scientific credentials
- Preferred: Experience preparing or reviewing regulatory submissions (IND, NDA, BLA, ANDA, MAA, or equivalent)
- Preferred: Experience with FDA-regulated manufacturing, quality, compliance, validation, or development environments
- Preferred: Experience performing quality reviews, regulatory audits, or scientific content evaluations
- Preferred: Experience with technical writing, structured reviews, or compliance assessments
- Preferred: Familiarity with AI model evaluation, prompt review, rubric development, or data annotation
- Preferred: Previous involvement in scientific, regulatory, quality, or technical content assessment activities
Benefits
Comp & perks- Remote work from an eligible location
- Flexible, assignment-based schedule
- Project-based freelance work
- Opportunity to contribute to advanced AI technologies
- Experience contributing to AI evaluation initiatives
- No AI background required
- Hourly compensation based on specialization, experience, qualifications, geographic location, and project requirements