Vedant More

verified-iconSenior Technical Lead – Medical Writing

Senior Medical Writing

Vedaqnt More is a Senior Medical Writing professional with 10+ years of experience developing regulatory and clinical documentation for medical devices. He specializes in authoring CERs, CEPs, SSCPs, and PMS reports in alignment with MDR and MEDDEV Rev. 4 guidelines. Skilled in literature review, data analysis, risk-benefit evaluation, and cross-functional collaboration, he leads documentation projects across multiple therapeutic areas while mentoring writers and ensuring regulatory compliance.

FORMERLY AT

HCL Technologies

LOCATION

Hyderabad, India

AVAILABILITY

Full-time

Skills

CER/CEP Writing

CER/CEP/SSCP Authoring

CER/CES Authoring

EndNote

Evidence Evaluation

Evidence Review

IFU Review

MDR/MEDDEV Rev 4

MS Office

PMS Data Analysis

PMS Plans

PMS Report Compilation

PubMed/Ovid/Embase Literature Search

Risk-Benefit Analysis

Work Experience

Medical Writer

MakroCare

July 2019 – February 2021

  • Authored and updated CERs, CEPs, and risk-benefit analyses for medical device submissions.
  • Reviewed literature summaries, PMS plans, and IFUs to ensure clinical accuracy and regulatory alignment.

TECHNOLOGIES

CER/CEP Writing, PMS Plans, IFU Review, Evidence Evaluation

Clinical Safety Associate II / Medical Writer

LAAN Research Pvt. Ltd

December 2014 – July 2019

  • Prepared CERs, CESs, and RBA reports. Conducted literature review and clinical evidence evaluation.
  • Collaborated with statistical teams to compile PMS data and supported regulatory submissions and document QC reviews

TECHNOLOGIES

CER/CES Authoring, Risk-Benefit Analysis, Evidence Review, PMS Report Compilation

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Clinical Data Manager

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Clinical Data Manager

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Medical Writer

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Regulatory Specialist

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Biostatistician

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Rajesh Chaturvedi

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Clinical Data Manager

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