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

• Remote | United States | Project-Based Independent Contractor
• Compensation: $20-$45 USD/hour, based on specialty, experience, and project requirements
• Help Shape the Future of AI in Healthcare

What if your pharmaceutical expertise could help artificial intelligence better understand regulatory requirements, scientific documentation, manufacturing processes, and quality standards?

At Volga Partners, we're connecting experienced pharmaceutical and biotechnology professionals with opportunities to contribute to the development and evaluation of advanced AI models.

We're seeking pharmaceutical regulatory, quality, manufacturing, compliance, and technical development professionals who can apply their industry expertise, scientific judgment, and regulatory knowledge to evaluate AI-generated pharmaceutical content.

This isn't a traditional pharmaceutical position. You won't be manufacturing products, preparing submissions, or managing quality systems. Instead, you'll assess complex scientific and regulatory content, identify technical inaccuracies, evaluate reasoning, and provide structured feedback that improves AI model performance.

Your pharmaceutical expertise is what matters. AI experience is a plus, not a requirement.

Important Note: This is a freelance, task-based role designed for those seeking supplemental income. It’s essential to understand the nature of freelance work—tasks will be assigned as they become available, and work may be irregular or intermittent.

The Opportunity

As a Pharmaceutical Subject Matter Expert (SME), you'll serve as a subject matter evaluator, helping assess the quality, accuracy, and reasoning of AI-generated pharmaceutical and biotechnology content.

You'll analyze scientific, regulatory, manufacturing, and compliance-related scenarios, identify errors or unsupported conclusions, and provide expert feedback grounded in industry standards, regulatory frameworks, and professional judgment.

Your contributions will help improve how AI systems understand and respond to complex pharmaceutical and biotechnology challenges.

Areas of Expertise We're Seeking

We're particularly interested in professionals with substantial knowledge and practical experience in one or more of the following areas:

1. CMC Regulatory Affairs

Professionals experienced in Chemistry, Manufacturing, and Controls (CMC) regulatory activities, regulatory submissions, lifecycle management, and global regulatory requirements.

2. Pharmaceutical Quality Assurance

Experts in quality systems, GMP compliance, deviation management, CAPA processes, quality oversight, and pharmaceutical quality operations.

3. CMC Science / Technical Development

Professionals involved in product development, formulation science, process development, scale-up activities, technology transfer, and product lifecycle support.

4. Regulatory CMC Submission Writing

Specialists experienced in CTD/eCTD authoring, Module 3 documentation, regulatory submissions, and technical regulatory writing.

5. Quality Control / Analytical Development

Experts in analytical testing, method validation, laboratory operations, data review, and analytical regulatory compliance.

6. GMP Compliance / Validation

Professionals with expertise in validation programs, qualification activities, GMP systems, and inspection readiness.

7. Regulatory Compliance Auditing

Experienced auditors who conduct internal, supplier, and compliance audits while evaluating quality systems and regulatory requirements.

8. Pharmaceutical Manufacturing / MSAT

Manufacturing and Manufacturing Science & Technology professionals experienced in process monitoring, troubleshooting, technology transfer, and operational excellence.

You do not need expertise in every area. We're seeking depth of knowledge within your particular specialization.

What You'll Do

• Evaluate AI-generated pharmaceutical content: Assess scientific, technical, and regulatory responses for accuracy, completeness, consistency, and compliance with industry standards.
• Review scientific and regulatory information: Examine content related to quality systems, manufacturing, validation, submissions, development, and compliance activities.
• Analyze technical reasoning: Determine whether AI-generated conclusions are supported by relevant scientific principles, regulatory expectations, and industry best practices.
• Identify errors and inconsistencies: Recognize unsupported claims, technical inaccuracies, missing context, and flawed reasoning.
• Validate information: Reference relevant FDA requirements, GMP regulations, ICH guidelines, and accepted pharmaceutical industry practices.
• Provide expert feedback: Clearly explain findings, identify opportunities for improvement, and recommend technically accurate corrections.
• Support AI quality improvement: Apply project-specific evaluation criteria, scoring guidelines, and quality standards.
• Complete independent evaluations: Use designated online platforms to complete assignments accurately and within established project timelines.
• Why Join Volga Partners?
• Apply Your Industry Expertise in a New Way
• Use the knowledge you've developed throughout your pharmaceutical or biotechnology career to contribute to advanced AI technologies.
• Help Improve Scientific Accuracy
• Your evaluations will help strengthen the quality and reliability of AI-generated pharmaceutical and regulatory information.
• Work Remotely
• Participate in project-based assignments from an eligible location, with flexibility based on project needs and availability.
• Explore the Future of Pharmaceutical Technology
• Gain experience contributing to AI evaluation initiatives while applying your existing scientific and regulatory expertise.
• No AI Background Required
• We're looking for professionals who can recognize accurate scientific reasoning, identify errors, and communicate expert assessments with clarity.

Requirements

• Who We're Looking For We're seeking experienced pharmaceutical and biotechnology professionals who bring more than familiarity with industry processes. You should be comfortable reviewing technical information, exercising independent judgment, and clearly explaining the reasoning behind your conclusions.
• Required Qualifications
• 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 pharmaceutical specialty listed above.
• 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.
• Must understand and be comfortable with a task-based freelance engagement model.

Preferred Qualifications

• We encourage applications from professionals with backgrounds such as: PharmD, PhD, or advanced scientific credentials.
• Experience preparing or reviewing regulatory submissions (IND, NDA, BLA, ANDA, MAA, or equivalent).
• Experience with FDA-regulated manufacturing, quality, compliance, validation, or development environments.
• Experience performing quality reviews, regulatory audits, or scientific content evaluations.
• Experience with technical writing, structured reviews, or compliance assessments.
• Familiarity with AI model evaluation, prompt review, rubric development, or data annotation.
• Previous involvement in scientific, regulatory, quality, or technical content assessment activities.
• Experience with AI model evaluation, large language models (LLMs), research, or structured quality assessments is beneficial but not required.