A subject matter expert (SME) is an individual recognized for deep knowledge in a specific domain or discipline. SMEs apply this expertise to guide decision-making, interpret complex information and ensure the accuracy and relevance of project activities, research outputs or policy recommendations. They are often consulted to provide specialized insight, validate methodologies, resolve specialized challenges, support training, or contribute to the design and evaluation of programmes.
In pharmaceutical drug development, SMEs are essential contributors to complex projects, where they ensure scientific and technical accuracy, provide strategic guidance and help maintain compliance with industry standard. Throughout the development process from early research to product launch, SMEs leverage their knowledge to mitigate risks and optimize outcomes.