プロフィール詳細

プロジェクトを作成

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Niranjan G.に依頼

India

Pharmaceutical Research Professional | Clinical Documentation | Regulatory Writing | GCP-Compliant Support |Cell Culture

プロフィール概要

I am a B.Pharm graduate currently pursuing a Master’s in Pharmaceutics, with hands-on experience in clinical research documentation, quality control operations, and healthcare data analysis. My professional background includes laboratory and analytical experience at HiMedia Laboratories, where I performed mammalian cell culture (multiple cell lines, routine passaging up to 10th passage), media preparation, and analytical testing using HPLC and Total Organic Carbon (TOC) systems while ensuring strict adherence to GMP, GLP, and data integrity standards. I have remote experience as a Research and Documentation Intern, where I conducted comprehensive literature reviews, interpreted clinical and non-clinical protocols, and developed structured regulatory-compliant technical documents. My expertise includes clinical documentation support, SOP development, protocol interpretation, and regulatory writing aligned with Good Clinical Practice (GCP) principles. Additionally, I have experience in healthcare data analysis and medical coding (ICD-10-CM, ICD-9-CM, HCPCS, CPT), along with foundational knowledge of CDISC standards (SDTM, ADaM) and Clinical SAS for data handling and analysis. My research background includes published review articles in oncology, pharmacogenomics, and cancer therapeutics, demonstrating strong scientific writing and evidence synthesis capabilities. I am particularly interested in supporting clinical research projects in areas such as protocol development assistance, literature review, regulatory documentation, clinical data management, and quality compliance support. I bring strong analytical skills, attention to detail, regulatory awareness, and the ability to work independently in remote environments while maintaining high standards of accuracy and confidentiality.

専門分野

• ☆ Cell Biology
• ☆ Stem Cell Research
• ☆ Drug Development
• ☆ Preclinical Research
• ☆ Vaccine Development
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology

サービス

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

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

Research Market Research, User Research, Meta-Research, Fact Checking, Gray Literature Search

Consulting Healthcare Consulting

Data & AI Image Processing, Image Analysis, Data Visualization

Product Development Formulation, Recipe Development, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing

職務経験

Lab Technician

Himedia Laboratories PvVt. Ltd.

9月 2025 - 12月 2025

Research and Documentation Intern

Clinivance Labs

7月 2025 - 10月 2025

Health Care Data Analyst

Unified Mentor

3月 2025 - 4月 2025

学歴

Master Of Pharmacy (Pharmaceutical )

Dr. Babasaheb Ambedkar Technological University

10月 2025 - 6月 2027

Bachelor of pharmacy

Dr. Babasaheb Ambedkar Technological University

11月 2022 - 7月 2025

Diploma In Pharmacy

Maharashtra State Board Technicial Education

12月 2020 - 7月 2022

認定資格

• Principles and Practice of Clinical Research 2024-2025

  National Institution of Health

  1月 2026 - 現在

• Drug development process

  Open Learn

  10月 2024 - 現在

• Good Clinical Practice

  NIDA Clinical Trials Network

  9月 2023 - 現在