Profile Details

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USD 250 /hr

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Hire Dr. Raj V.

United States

USD 250 /hr

Regulatory affairs expert; Ph D with 20+ years experience in pharmaceutical and clinical research

Profile Summary

Experienced scientific and regulatory affairs professional, trained in drug discovery and development working with novel small molecule drugs, biologics, antisense oligonucleotide drugs (ASOs), and gene therapy drugs; spearheaded business strategy developments for new product initiatives across the FDA, HealthCanada, EMA, and other global areas supporting academic physicians and industry sponsors; devised execution plans for scientific investigations, technology support, and various regulatory filings in various milestones throughout the life-cycle of IND studies, e.g., extending from project conceptualization through the closing of studies and beyond (drug repurposing in post-marketing); worked in multiple therapeutic areas (oncology, neurodegenerative diseases, rare pediatric and orphan diseases, diabetes, infectious diseases) in a variety of roles including scientific quality and compliance; can provide advice on material content for medical science, training programs, scientific articles, and research grants.

Subject Matter Expertise

• ☆ Drug Discovery
• ☆ Drug Target Identification
• ☆ Drug Development
• ☆ Preclinical ADME/PK/PD
• ☆ Preclinical Research
• ☆ Pharmacogenomics
• ☆ Preclinical Pharmacology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Drug Efficacy Testing
• ☆ Healthcare Administration & Management
• ☆ Medical Affairs
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Non-GMO Products
• ☆ Product Evaluation
• ☆ Stability Testing
• ☆ Concept Development
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ User Research
• ☆ Quantitative User Research
• ☆ Meta-Research
• ☆ Feasibility Studies
• ☆ Technology Scouting
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Process Design
• ☆ Instructional Webinars
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ Experimental Protocols
• ☆ Science Communication
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ Grant Writing

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Non-Medical Regulatory Writing, Technical Writing

Research Market Research, Feasibility Study, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Predictive Modeling

Product Development Product Evaluation, Manufacturing, Product Compliance , Concept Development

Work Experience

The University of Texas Southwestern Medical Center

- Present

REGULATORY SCIENTIST

University of Texas Southwestern Medical Center at Dallas

January 2020 - Present

Education

Ph D (Botany)

Washington State University

September 1981 - October 1986

Certifications

• Ph. D

  Washington State University

  December 1986 - Present

Publications

JOURNAL ARTICLE

Raj Ph D .

Raj Ph D .

Raj Ph D .

Raj Ph D .

Raj Ph D .

Raj Ph D .

Raj Ph D .