Regulatory Compliance Research Scientist and Study Director with 15-plus years' experience in pharmaceutical and medical device development industries. Well-rounded global professional with expertise in managing all aspects of research study requirements including design, execution, data interpretation, and getting results. Compiling safety documents for regulatory submissions, providing responses to FDA inquiries, and participation in advanced FDA review processes in a fast-paced highly regulated matrix environment. Teach colleagues methodology. Computer and remote-friendly.

Highlights:

Companies I like:

Pharma OR Biotech, Baxter

• Good Laboratory Practices
• Management
• Quality Assurance
• Test
• Cardiovascular
• Critical Care - Neurology
• Immunology
• Infectious Diseases
• Neurology
• Oncology