Subject Matter Expert

General role description

Subject Matter Experts provide deep technical or scientific expertise to support clinical research, regulatory submissions, or product development. In Contract Research Organisations (CROs) and pharmaceutical, biotechnology, or medical device companies, SMEs contribute to study design, ensure scientific accuracy, and help interpret complex data. They may specialise in a particular therapeutic area, technology, or methodology, and often work across departments to guide best practices, train colleagues, and support regulatory or client-facing deliverables.

Key tasks and responsibilities

  • Provide scientific or technical guidance on projects within a defined area of expertise
  • Contribute to study design, protocol development, and review of clinical or regulatory documents
  • Ensure the scientific accuracy of materials submitted to regulators, clients, or internal stakeholders
  • Collaborate with cross-functional teams including clinical operations, regulatory affairs, biostatistics, and data management
  • Deliver training, mentoring or expert reviews to internal teams or external partners

Workplace settings

  • Pharmaceutical, biotechnology and medical device companies
  • Contract Research Organisations (CROs)

Required qualifications

  • A degree in a relevant life science, medical science, pharmacy, or engineering field
  • A Master’s degree or PhD is often preferred depending on the specialisation

Other notable requirements

  • Several years of experience in clinical research, product development, or regulatory science
  • Deep knowledge in a specific therapeutic area (e.g. oncology, neurology), technology, or research methodology
  • Experience working in cross-functional teams or client-facing roles
  • Excellent communication skills and the ability to explain complex information to diverse audiences

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