Vivek Damodar Ranjan

Regulatory Writer Ii @Certara

Oxford, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2024 — Present

Regulatory Writer Ii @Certara

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Oxfordshire, GB

Responsible for the production of clinical and other scientific study documents for regulatory submission. Documents include investigator’s brochures, periodic benefit-risk evaluation reports, clinical study reports, risk management plans, protocols and narratives. Perform quality control and editorial review of a range of regulatory and scientific documents. Participate in client project teams and conduct kick-off/comment resolution meetings. Conduct reviews of literature to support regulatory submissions.

EDUCATION

2016 — 2020

Nanyang Technological University Singapore

Doctor of Philosophy (Ph.D.), Multi/Interdisciplinary Studies

2007 — 2011

RV College Of Engineering

BE, Mechanical Engineering

2014 — 2015

Nanyang Technological University Singapore

Master of Science (MSc), Mechanical Engineering

SKILLS

AutomotiveGermanEngineering Design ReleaseEngineeringDfmFemManufacturingStructural AnalysisGeometric Dimensioning & TolerancingMechanicalMechanical EngineeringProject ManagementProduct DesignProduct DevelopmentRoot Cause AnalysisFailure Mode and Effects Analysis (Fmea)ComsolPro EngineerFinite Element AnalysisDesign for ManufacturingDfaPtc Pro/EngineerFmeaMicrosoft OfficeDesign ReviewPtc CreoVehicle ArchitectureAdditive Manufacturing

ABOUT VIVEK DAMODAR RANJAN

I am a regulatory writer supporting a wide range of projects, encompassing clinical documents, aggregate reports and literature reviews. I am an active member of the European Medical Writers Association and have also worked in multiple therapeutic areas, including autoimmune disease, diabetes, cardiology, cell-based medicinal products, dermatology, neurology, oncology, respiratory, and vaccines.Outside of work, I am an avid reader, blogger and a sci-fi film enthusiast. Feel free to connect with me or send me an email: v••••••••@gmail.com

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Vivek Damodar Ranjan — Regulatory Writer Ii at Certara in Oxford, GB | Unifers