Steve Sibleyは、製薬業界で30年以上の経験を持ち、Certara Drug Development Solutions（CDDS）において薬事文書作成のコンサルティングを提供するとともに、グローバル申請サービス部門の責任者を務めています。He has led global submission teams and authored critical documentation on more than 45 marketing applications and more than 30 investigational drug applications. Sibley has particular expertise in briefing documents, regulatory defense, and submission planning. Sibley’s work has covered the full range of therapeutic areas and program types, with a particularly strong background in oncology, cardiology, and rare diseases, including participation in health authority meetings and advisory committee meetings. His experience is truly global, having worked in project teams encompassing the United States, the European Union, Australia, and Asia. Sibley draws on his substantial industry knowledge and leadership skills to mentor and train other submission leads.