Clare Salamon

Background

About Clare Salamon

Scientific Writer of Regulatory submissions (INDs, NDAs, MAAs). Responsible for the planning, preparation, and review of the nonclinical sections of regulatory submissions as well as review of the clinical sections to ensure consistency and accuracy. Extensive knowledge of US/EU requirements for clinical trial implementation and drug approval. As a toxicologist, participated in several project teams representing the toxicology function in drug development and managed a group of Scientific Document Analysts responsible for the QC of the submissions. Responsibilities included interaction with US and EU reviewers; authoring responses to Agency questions; and authorship and review of the nonclinical sections of product labels. Provided direction and assistance regarding submission requirements and regulatory issues. Practiced team concept management style with hands-on approach. Consistently performed at peak competence while meeting new challenges in results driven, constant change environments. Participated in global teams evaluating methods for improving regulatory submission processes.