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Dr Kaif
@dr_kaif22
Scientific Writer
India
Inglés, Hindi, Gujarati
Sobre mí
I am a PharmD-qualified Senior Medical Writer with experience at Vivoclin Research Services, specializing in clinical trial documentation, regulatory writing, and evidence-based medical content.
I bring deep expertise in crafting ICFs, clinical study protocols, SOPs, CSRs, and patient-facing documents that meet ICH-GCP, FDA, and EMA standards. My pharmaceutical background ensures scientific accuracy, regulatory compliance, and clarity in every document I deliver.
Whether you're a CRO, biotech startup, pharma company, or independent researcher — I help you get trial-ready documents faster.
Habilidades
Dr Kaif
desconectado •
Tiempo medio de respuesta: 2 horas
Revisa mis servicios
Investigación y resúmenes
I will write a professional icf for clinical trials
Porfolio
Experiencia laboral
Senior Medical Writer
Vivoclin Research Services • Tiempo completo
Jun 2024 - Present • 1 yr 11 mos
Senior Medical Writer Vivoclin Research Services | Ahmedabad, India Working as a Senior Medical Writer at Vivoclin Research Services, a clinical research organization (CRO) based in Ahmedabad, specializing in end-to-end clinical trial documentation and regulatory medical writing. Core responsibilities include: Authoring and reviewing Informed Consent Forms (ICFs) ensuring full compliance with ICH E6(R2) GCP, FDA, EMA, and CDSCO guidelines Writing and editing Clinical Study Protocols, Investigator Brochures (IB), and Standard Operating Procedures (SOPs) Developing patient-facing documents with appropriate plain language and readability standards Collaborating with clinical, regulatory, and data management teams to ensure document accuracy and timeline adherence Supporting IRB/IEC submissions with complete trial documentation packages Ensuring audit-ready documentation across all trial master files Therapeutic areas covered: Neurology, Oncology, Psychiatry, and Rare Diseases
Clinical Trial Assitant
Cliantha Research • Tiempo parcial
Aug 2023 - Mar 2024 • 7 mos
Clinical Trial Assistant Cliantha Research | Ahmedabad, India Worked as a Clinical Trial Assistant at Cliantha Research, a leading CRO based in Ahmedabad, supporting end-to-end clinical trial operations across 3 clinical trials. Responsibilities included Trial Master File (TMF) management ensuring audit-ready documentation at all times, site coordination and communication with investigators and site staff, IRB/IEC submission support, and data entry with CRF review for accuracy and completeness. Successfully supported 2 internal audits with zero critical findings, demonstrating strong adherence to ICH-GCP guidelines and regulatory compliance standards.
