Meticulous and Reliable Virtual Assistant

  • 560021 Bangalore India 
  • Graduation: M.Pharmacy (Pharmacology)

  • Hourly / Daily / Monthly Rates: 6 / hour 50 / daily 1000 / monthly

  • Languages: English(Full Professional) | Hindi(Full Professional)

  • Last Update: 05.01.2020 at 03:43

Job Type
Off Site Remote
Not Available

Category :

Regulatory, Quality, and Clinical


Keywords :


Key Account Manager


  • Preparation and submission of eCTD filing of formulation dossiers for US, Europe.
  • Compilation and validation of electronic regulatory submissions in accordance to US, EU and domestic regulatory bodies including State FDA, DCGI etc.
  • Worked on validation of eCTD submission through Lorenz, EURS/Global and Insight validator software
  • Perform Datavision searches to locate original disclosures and other resources (journal sites like Pub-med, Research gate, Elsevier etc.) where necessary
  • Worked on Pre-Publishing activities i.e., Doc-Prep with ISI tool box and Smart Desktools.
  • Worked on complete eCTD preparation with eCTD express and Insight publisher software.
  • Resolving validation related and publishing related errors/issues
  • Fluent in English with excellent writing and good communication skills.
  • Led successfully a team of 10 to complete two projects and got appreciation from the firm.
  • Excellent basic computer skills in MS office, MS Excel, and SharePoint applications and data base.


Pharmacovigilance - EVPRM creation, IDMP

Regulatory Publishing - eCTD publishing and validation

USFDA Annual Report Preparation

Clinical document formatting, document level publishing

Clinical doument redaction

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