Profile Details

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Hire Janita ..

Canada

USD 20 /hr

Freelance content Medical Writer | Expertise in Clinical Research | Pharmacovigilance | Drug Regulatory affairs

Profile Summary

I am a result-oriented professional with 8+ years of experience spanning across academic, research, and industry. I am qualified as a Master of Pharmacy with a specialization in Pharmaceutical Chemistry with an insight of various health guidelines like Health Canada, US FDA, EMEA and ICH. I have hands on experience in handling sophisticated lab Instruments such as UV/Visible Spectrophotometer, High performance liquid chromatography(HPLC) and a strong knowledge as well as as practical experience in Analytical method Development and Validation. I also have an expertise in drafting the scientific documents like research papers and review articles.

Subject Matter Expertise

• ★ Pharmaceutical Regulatory Affairs
• ★ Clinical Trials
• ★ Pharmacovigilance/Drug Safety Monitoring
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ Medicinal Chemistry
• ☆ Structure-Activity Relationship (SAR) Studies
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Microbiology Testing
• ☆ Drug Stability Testing
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Drug Efficacy Testing
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Technology
• ☆ Medical Equipment & Supplies

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting

Research Scientific and Technical Research

Consulting Healthcare Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Quality Assurance & Control (QA/QC)

Work Experience

Assistant Prof

Chitkara University

February 2015 - April 2022

Education

Post-Graduate Diploma in Clinical Research and Regulatory Affairs

Academy of Applied Pharmaceutical Sciences

July 2022 - Present

Masters in Pharmaceutical Chenistry

Punjab Technical University

June 2010 - July 2012

Certifications

• CR09 The Canadian Pharmaceutical Industry

  AAPS

  January 2022 - Present

• Clinical Pharmacology and Clinical Safety Assessments Certificate

  AAPS

  January 2022 - Present

• Clinical Research Regulations and Good Clinical Practices (GCP) Certificate

  AAPS

  January 2022 - Present

• Legislations, Ethics and Good Pharmacovigilance Practices (GVP) Certificate

  AAPS

  January 2022 - Present