Janine Pool
Chief Innovation Officer
415.420.6987
jp@poised4success.com

Regulatory Expertise

• Knowledgeable of FDA regulations and ICH guidelines
• Familiar with documentation requirements for all stages of drug development and safety reporting
• Experience converting legacy content into eCTD structure
• Over 14 years successful processing, publishing, and archiving US and ROW electronic dossiers with no RTFs
• Primary contact for interactions with FDA. Active DIA and RAPS member

Management Skills

• Proven track record managing cross-functional project teams to exceed corporate goals
• Demonstrate strong oral, written, and presentation skills to communicate and interact effectively with personnel at all organizational levels
• Excellent organization, collaboration, and problem solving skills in positions demanding attention to detail and flexibility to manage competing priorities and timelines

Technical Knowledge

• Analyze business processes to design enterprise-wide, integrated solutions to standardize and optimize operations
• Design information architecture structure, databases, websites, and templates
• Desktop publishing and document management system super user (Word, Acrobat, ISI Toolbox, eCTD Xpress, Core Dossier, ViewPoint, LiveLink, Documentum)