Profile Details

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Hire Samantha S.

United States

USD 45 /hr

MBA/MSN-RN and six sigma green belt

Profile Summary

Senior Medical Writing professional and Registered Nurse with over 15 years of experience within the regulatory and clinical trial healthcare atmosphere. Expert in bridging clinical expertise, regulatory compliance, and business operations to lead high-volume narrative delivery for global pharmacological trials and architect AI-driven process improvements. Specialized in ICH guidelines and pharmacovigilance, supported by a strong background in both patient care and corporate finance.

Subject Matter Expertise

• ☆ Microbiology
• ☆ Virology
• ☆ Coronaviruses
• ☆ Enteroviruses
• ☆ Adenoviruses
• ☆ Biostatistics
• ☆ Neuroscience
• ☆ Neurochemistry
• ☆ Behavioral Neuroscience
• ☆ Cognitive Neuroscience
• ☆ Neuropsychology
• ☆ Developmental Neuroscience
• ☆ Neuropharmacology
• ☆ Neurobiology
• ☆ Ecology
• ☆ Forensic Genetics
• ☆ Development Economics
• ☆ Logic
• ☆ Dance
• ☆ Pharmacy
• ☆ Drug Discovery
• ☆ Drug Design
• ☆ Drug Development
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Drug Efficacy Testing
• ☆ Vaccine Development
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Clinical Trials
• ☆ Public Health
• ☆ Disease Control And Prevention
• ☆ Community Health Services
• ☆ E-Health & Telemedicine
• ☆ Healthcare Administration & Management
• ☆ Hospital & Medical Facility Management
• ☆ Managed Healthcare
• ☆ Medical Billing
• ☆ Medical Affairs
• ☆ Healthcare Quality Improvement
• ☆ Psychiatry
• ☆ Child & Adolescent Psychiatry
• ☆ Neuropsychiatry
• ☆ Forensic Psychiatry
• ☆ Addiction Psychiatry
• ☆ Psychopharmacology
• ☆ Cognitive Behavioral Therapy
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Product Evaluation
• ☆ Supply Chain & Logistics
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Peer Review
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ PreMarket Approval (PMA) Applications
• ☆ NDA/BLA Applications
• ☆ Clinical Trial Documentation
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Research Summaries & Abstracts
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ Case Studies
• ☆ Scientific Proofreading & Editing
• ☆ Creative Writing
• ☆ Statistical Finance
• ☆ Accounting
• ☆ Business Finance
• ☆ Business Operations
• ☆ Business Strategy
• ☆ Data-Driven Decision Making
• ☆ Health Economics
• ☆ Consumer Behavior & Theory
• ☆ Macroeconomics
• ☆ Microeconomics
• ☆ Behavioural Economics
• ☆ Medical Law
• ☆ Branding
• ☆ Marketing Strategy
• ☆ Marketing Analytics
• ☆ Business Intelligence
• ☆ Socioeconomics
• ☆ Six Sigma
• ☆ Banking

Services

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

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Business & Legal Writing, Creative Writing, General Proofreading & Editing

Research Market Research, Fact Checking, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Image Processing, Image Analysis, Data Insights

Product Development Product Evaluation, Product Validation, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development

Work Experience

Senior Medical Writing Manager, Narrative Expert

Genmab

October 2022 - Present

Associate Medical Writer

Medpace

April 2020 - September 2022

Safety Specialist II

Cincinnati Children's Hospital Medical Center

November 2012 - March 2020

Registered Nurse

Cincinnati Childrens Hospital Medical Center

March 2010 - November 2012

Education

MBA

Ball State University

September 2008 - May 2014

MSN

Mount Saint Joseph College - United States

May 2009 - August 2010

Certifications

• Registered Nurse

  Ohio Board of Nursing

  October 2025 - May 2026

• Lean Six Sigma Green Belt

  IASSC

  May 2014 - May 2017