Medical Device Software
Resume:
Joshua Sharlin. Resume
Joshua Sharlin, Ph.D.
Washington, D.C.
Tel: +1-301-***-**** email: ********@********.***
www.speedupfda.com
Summary: Dr. Sharlin has practical hands-on experience in many aspects of drug, biologic and
medical device development including; regulatory affairs, protocol development, design and
execution of studies, data collection, data management, data reporting, statistical analysis,
software programming and validation, technical writing, and FDA compliance. He is an expert in
the collection, analysis, interpretation and presentation of information for FDA.
Highlights of Skills, Services & Experience
FDA drug reviewer, FDA statistician, instructor for SAS Institute
Experience with drugs, biologics and medical devices
Authority in 21 CFR Part 11 compliance and assessment
Teach audioconferences and customized onsite training classes
Audit CROs, sponsors and vendors for FDA compliance
Regulatory affairs and GCP compliance expert
Write and improve submissions, protocols and SOPs
Consulting Services
Write SOPs
Applied my compliance knowledge and insight into the expectations of auditors and FDA
reviewers to write and improve SOPs on a wide variety of regulatory and technical topics. Wrote
SOPs about all aspects of good clinical practice (GCP), software validation and 21 CFR Part 11
compliance and all elements of information technology infrastructure.
Perform Audits for Compliance and Capability
Conducted capability audits of CROs for sponsor companies. Performed mock audits of sponsor
companies to provide assurance that they will pass an FDA audit. Evaluated CRO compliance in
advance of customer audits.
Audited for GCP compliance, information technology infrastructure and all elements necessary for
the collection, analysis, interpretation and presentation of information to FDA.
Validate Software
Wrote SOPs and created the required documentation so in-house developed software or software
intended for sale to FDA-regulated companies met all requirements in 21 CFR Part 11.
Conduct Training
Developed over 40 classes on a wide-range of technical and regulatory topics including safety
reporting, 21 CFR Part 11 validation, SAS programming and statistical topics. Trained over
50,000 thousand people from more than a thousand of FDA-regulated companies. Developed
customized classes for company staff while solving problems and producing deliverables.
Joshua Sharlin. Resume
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Consulting Services (continued)
Write and Review Submissions, Protocols, Statistical Analysis Plans and Study Reports
Reviewed and wrote submissions, protocols and statistical analysis plans. Improved their content
and structured information to be more useful to FDA reviewers. Predicted problems and issues
likely to be raised by FDA reviewers and added information to answer these expected questions.
Execute Statistical Analysis
Provided advice on statistical issues and performed statistical analysis.
Improve SAS Programming Compliance & Write SAS Code
Wrote SOPs for SAS programming. Validated the installation and maintenance of SAS software.
Ensured that SAS code and documentation met FDA s compliance expectations. Used SAS to
perform data manipulation, reporting and statistical analysis. Improved the efficiency and skill of
SAS programmers.
Solve Regulatory Problems
Assisted companies in the development of a regulatory strategy. Wrote answers to questions from
FDA reviewers. Developed solutions to regulatory and information problems identified by FDA.
Presented information at meetings attended by FDA reviewers.
Experience
FDA Reviewer
Managed the drug review process. Instructed firms on how to proceed with drug approval.
Summarized outstanding problems and issues with protocols and studies, and determined if
deficiencies were adequately addressed. Authored all written communication to the sponsoring
firm and integrated comments from other reviewers.
Consultant to FDA-Regulated Industry
Eighteen years of experience working with drug, biologic and medical device companies of all
sizes. Assisted academic research institutions in improving FDA compliance. Wrote proposals and
developed project plans. Worked with scientific experts on the sponsor s staff to solve problems
related to regulatory affairs and approval strategy. Conducted background research to solve
regulatory and scientific problems affecting the likelihood of product approval. Developed
reviewer-friendly solutions to technical and compliance problems. Audited companies, CROs and
software vendors for FDA compliance. Validated purchased software and software developed in-
house. Wrote and reviewed SOPs, protocols and study reports. Improved the quality and
efficiency of software development that supported product submission. Investigated and solved
study randomization problems. Developed information that documented FDA compliance. Wrote
responses to FDA letters and presented information to FDA reviewers. Member of the Booz-Allen
team hired by FDA to perform an analysis to explain why some drugs were approved without
review cycles.
SAS Institute Instructor
Taught programming classes for SAS Institute. Selected and trained new instructors.
Scientist
Designed and conducted scientific experiments in the areas of physiology and toxicology. Hands-
on experience with a wide variety of laboratory equipment and lab analysis techniques.
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Experience (continued)
Manager of Large Scale Software Development Projects
Planned and managed the execution of numerous large software development projects for
commercial and federal government customers including Marriott Hotels, Dept of the Navy and
the Bureau of Labor Statistics (Consumer Price Index).
Statistician
Worked as a statistician for the U.S. Department of Agriculture and for the FDA. Taught statistical
analysis and study design to scientists.
Trainer and Course Developer
Developed training for scientists in computerization and analysis of data. Created and taught
instructor-led classes in SAS validation and FDA compliance. Wrote and taught over 40 different
audioconference classes on a wide variety of FDA regulatory, technical and compliance topics.
Taught FDA compliance to students in India using Skype.
Audioconference Topic Number of
Presentation Titles
1 Part 11 Compliance and Software Validation 5
2 The FDA Database: ClinicalTrials.gov 4
3 How to Write SOPs 3
4 Clinical Trials Conducted Outside the U.S. 2
5 Understanding FDA Reviewers, Compliance and the 5
Review Process
6 Safety Reporting for Drugs 3
7 Improving the Analysis and Presentation of Study 3
Results
8 FDA Requirements for Reports, Labels and Advertising 3
9 Generic Biologics 1
10 How to Analyze Trial Results - Help for Non- 3
Statisticians
11 SAS Programming 5
12 Electronic Submissions 5
13 Medical Devices 3
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Employment History
1994-present Sharlin Consulting, Washington, DC
Consultant
FDA compliance expert, trainer, SAS programmer, statistician, technical writer,
and auditor. Authority on auditing, writing NDAs, protocols and SOPs.
Authority on validation and 21 CFR Part 11 compliance.
1992-94 Food & Drug Administration, Rockville, MD
Drug Reviewer
Reviewed clinical studies and managed the drug review process.
1989-92 Marriott Hotels & Resorts, Bethesda, MD
Director, Hotel Customer
Information Systems
Managed a programming staff of 21 with a $4 million annual budget.
1981-89 ORI, Inc., Rockville, MD
Consultant
Manager and programmer on software development projects for healthcare
companies and federal government agencies including the National Institutes of
Health (NIH).
1977-81 University of Georgia, Athens, GA
Research Scientist
1975-77 U.S. Dept of Agriculture, Beltsville, MD
Statistician
Education
Ph.D. Physiology University of Georgia
M.S. Physiology University of Maryland
B.A. Zoology University of Iowa
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