Saksh Theurkar
Medical Content Writer and Clinical Research Associate
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About
Results-driven Medical Content Writer and Clinical Research Associate with hands-on experience in medical writing, pharmacovigilance, regulatory affairs, and clinical data management. Proficient in producing high-quality, plagiarism-free medical content including patient-information documents, OSPE case documentation, safety narratives, and regulatory submissions. Experienced with EDC systems (Medidata Rave), Veeva Vault, MedDRA coding, and AE/SAE reporting.
Adept at translating complex clinical data into clear, accurate, and compliant documentation in accordance with ICH-GCP guidelines.
Experience
Medical Content Developer / Writer at Immersivision Technology Pvt. Ltd. (2025 – Present)
- Develop and maintain 300+ OSPE case documents covering gross anatomy, patient cases, and radiology, including 2D image generation and clinical descriptions.
- Author plagiarism-free medical content (articles, patient-education materials, informational documents) ensuring clinical accuracy, clarity, and ethical standards.
- Edit, upscale, and merge medical and radiology images; generate AI-assisted educational graphics using tools such as Chatgpt.
- Produce regulatory-grade documentation and health content aligned with organizational Quality Standards.
- Troubleshoot and optimize clinical content systems; perform data entry, validation, and QA/QC processes.
- Collaborate cross-functionally with developers and designers to integrate text and visuals for digital educational platforms.
Clinical Research Intern at Bion CRO (Bion India Pvt. Ltd.) (2025)
- Pharmacovigilance and Regulatory Affairs: Performed AE/SAE reporting, MedDRA coding, and case processing; authored safety narratives; prepared regulatory documentation per ICH-E2A guidelines. Utilized Veeva Vault for document management, safety case tracking, and regulatory submission workflows.
- Clinical Data Management: Operated Medidata Rave (EDC) for data entry, validation, cleaning, and QA/QC checks; ensured data integrity throughout the trial lifecycle.
- Clinical Trials Support: Assisted in BA/BE study execution across Phases I-IV; supported site operations including screening, check-in, and dosing; maintained Trial Master Files (TMF).
- Clinical Documentation: Drafted study protocols, CRFs (Case Report Forms), and ICFs (Informed Consent Forms); ensured SOP compliance and GCP adherence.
- Quality Assurance: Participated in internal audits, compliance checks, and documentation control activities.
Education
Advanced Diploma in Clinical Research – HR Remedy India Pvt Ltd, Pune (2025)
B.Tech in Biotechnology – Dr.
Balasaheb Kokan Krishi Vidyapeeth
Dapoli | College of Agri-Biotechnology, Saralgaon, Thane (2024)
12th Science (HSC) – Vidyadham Jr. College of Science, Shirur (2020)
10th (SSC) – Vidyadham Prashala, Shirur (2018)
