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