Skills And Experiences

  • Scientific and Medical Writing and Editing
  • Project Management
  • Archive Design and Management
  • Reporting
  • Database Development
  • Numerical Data Mining
  • Data Management
Extensive experience managing early safety and toxicology studies:
  • Authoring and reviewing reports for inclusion in worldwide regulatory submissions
  • Develop and edit documents for optimum presentation to facilitate internal and agency review and provide consistency with supporting documents
  • Develop strategies for producing paper and electronic Investigational New Drug (IND) and drug product market applications consistent with current U.S. and International Committee on Harmonization (ICH) guidelines
  • Provide training in the development and use of templates for paper and electronic drug marketing submissions
  • Provide interim management and oversight for clients