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Chetna Joshi

Chetna Joshi

M.Pharma in Pharmacology

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location of Chetna JoshiGhaziabad, Uttar Pradesh, India

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  • Timeline

  • About me

    Manager at APCER Life Sciences

  • Education

    • Hermann Gmeiner School. Bhimtal,Nainital

      1998 - 2005
      Higher Secondary Science

    • Kumaun University

      2006 - 2012
      Masters in Pharmacy Pharmacology First Class with Honors

  • Experience

    • Kumaun University (2010-12)

      Aug 2010 - Aug 2012
      M.Pharma in Pharmacology

      Pursued M.Pharma in Pharmacology ( Ist Division with Honors) and as a part of curriculum completed a one year project work at Institute of Cytology and Preventive Oncology, NOIDA on topic entitled "Variation analysis of Long Control Region of Human Papilloma virus 16 in cervical cancer patients and the effect of certain anticancer drugs on Transcription factor YY1" using various molecular biology techniques like PCR, Western Blotting, DNA sequencing etc.

    • Institute of cytology and Preventive Oncology, Noida

      Aug 2011 - Aug 2012
      Project Trainee

      Collected biopsies of cervical cancer patients and extracted their protein and DNA for qualitative and quantitative estimation. Sequenced the genome of HPV 16 LCR infected patients. Targetted the cervical cancer cells with anticancer drugs like curcumin and paclitaxel and studied their effect using western blotting. Learned various molecular biology techniques like PCR, EMSA, Immunohistochemistry, Flowcytometry, Tissue culture techniques etc

    • Delhi Institute of Pharmaceutical Sciences and Research, University of Delhi

      Jul 2013 - Mar 2014
      Lecturer

      Teaching Pharmacology, Pathophysiology and Toxicology to Undergraduate Students.

    • APCER Life Sciences

      Apr 2014 - now

      • Develop and maintain excellent working relationships with clients and internal/external contacts. • Provide expert medical writing services guidance to internal and external stakeholders. • Reviewing (drafting if required) of assigned medical writing documents which includes but not limited to regulatory documents such as IBs and IB Amendments, CSRs for Phase I-IV studies, narratives, protocols, ICFs, Briefing documents for NDA/MAA/BLA submissions, web synopses, CTD Modules 2.4-2.7, 4, and 5 (including ISS and ISE), label updates including product information/SmPC, PILs, and medication guides, clinical expert statements to support Type 2 Variation Filings/RFIs in accordance with Article 8(3), 10(a), 10(b), 10(c), 10(1), and 10(4) (EU submissions) etc.• Lead and guide the medical writing team to ensure that medical writing projects deliver the value expected of the engagement, including quality, compliance, budget, and timelines. • Interact with client and other stakeholders (internal and external) in order to achieve required outcomes and meet timelines.• Monitoring the work progress, ensuring timely delivery, participating in status meetings, updating project progress to the stakeholders.• Generation, review and execution of company Standard Operating Procedures (SOPs) and Work Instructions (WI).• To carry out the necessary administrative duties required for the job.• Other duties as assigned by management.Other responsibilities include: Project management. Team management. Execution of Company SOPs. Complete required training on new and revised procedures and update training file in a timely manner. To impart trainings across company, as assigned by the reporting manager. Train and mentor new employees in medical writing, as required. Compliance to project guidelines. Maintain awareness of changes to/new regulations affecting medical writing activities. Show less Drafting and reviewing protocols, clinical study reports, investigator brochures, regulatory documents and others.1. Regulatory documents for generic filings Modules 2, 4 & 5 of the common technical document- Pre- clinical and clinical overview- Labels: Prescribing information, patient information leaflet, Summary of product characteristics (SmPC)- Clinical expert statements- Establishing core SmPC/SmPC comparison2. Protocols, Clinical study reports, narrativesDrafting protocols, narratives, and clinical study reports3. Investigator brochuresDrafting and reviewing investigator brochures (updates) across various therapeutic areas 4. Training and mentoring of team members Show less

      • Manager

        Apr 2023 - now

      • Deputy Manager

        Apr 2021 - Mar 2023

      • Assistant Manager

        Apr 2019 - Apr 2021

      • Team Lead

        Apr 2017 - Mar 2019

      • Senior Medical Writer

        Apr 2016 - Mar 2017

      • Medical Writer

        Apr 2014 - Mar 2016

  • Licenses & Certifications