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Summary of Dr. Sharlin’s Consulting Experience
Having both prepared submissions for many FDA-regulated companies and reviewed submissions as an FDA reviewer, Dr. Sharlin knows both sides of the approval process. He has hands-on experience in the entire approval process for drugs, medical devices and biologics including:
- Create a regulatory strategy,
- Write and improve SOPs, protocols, study reports, and annual reports
- Audit for GCP compliance
- Design a study,
- Set up a database,
- Report on and analyze data,
- Interpret study results,
- Prepare FDA submissions.
Software Development & Information Technology Experience
Dr, Sharlin has significant hands-on experience in software development and information technology. This includes programming and implementing large database systems. Before working as an FDA reviewer, he was director of customer information systems at a Fortune 250 company. This knowledge has been applied to FDA-regulated companies as follows:
- Audit companies and systems for compliance with 21 CFR Part 11 (electronic records and electronic signatures),
- Database design,
- SAS programming,
- Improve efficiency and skill of SAS programmers,
- Validation of software systems (built in-house and purchased).
Train Your Staff While Producing Deliverables
Dr, Sharlin emphasizes applying his teaching skills while doing work. While completing a project he’ll improve the FDA-related knowledge and insight of your staff.