Our specialists’ previous employers

HIRE Medical Writers (Regulatory & Clinical)

Albert C

Medical Writing

Albert C. is an experienced Medical Writing professional with 10+ years in clinical and regulatory documentation for pharmaceuticals and medical devices. He specializes in authoring CERs, PMS/PSUR/PMCF reports, and Risk Management deliverables under MDR, MEDDEV Rev. 4, ICH, FDA, and EMA guidelines. Skilled in literature research, data evaluation, and cross-functional collaboration, she leads writing projects end-to-end while mentoring teams and ensuring regulatory accuracy and compliance.

CER

Clinical Monitoring

Data Review

Embase

MDR/ICH/FDA/EMA compliance

Medline

OvidSP

PMCF

PSUR

PubMed

Regulatory Compliance (MDR)

Risk Management Documentation

+1 More

Manikanta K

Medical Writing

Manikanta K is a Medical Writing professional with nearly 10 years of experience in authoring and reviewing regulatory and clinical documents for global submissions. He specializes in study protocols, clinical/bioanalytical study reports, IBs, ICDs, and IMPDs in alignment with ICH and international regulatory guidelines. Skilled in QC review, PK analysis, and cross-functional coordination, he has supported audits from DCGI, WHO, ANVISA, and USFDA while mentoring teams and ensuring high-quality, submission-ready deliverables.

BA/BE Documentation

Cross-functional Review Management

eCTD Documentation

ICH E3 CSRs

Phoenix

Phoenix 8.0

PK Data Analysis

Protocol & CSR Development

Protocol/CSR/IB Authoring

SOP Review

WinNonlin

Latika Kumar

Senior Medical Writer

Latika Kumar is a Senior Medical Writer with 8+ years of experience in authoring and reviewing clinical and regulatory documents, including CSRs, patient narratives, protocols, ICFs, IBs, manuscripts, and posters. Skilled in ICH E3–compliant writing, scientific accuracy, quality review, and mentoring writers, she manages multiple projects end-to-end while ensuring regulatory alignment and on-time deliverables.

Clinical & Regulatory Documentation (CSRs

CSR & Narrative Authoring

Document Tracking Tools

IBs)

ICFs

ICH E3 Guidelines

MS Office

Narratives

Protocol/ICF/IB Development

QC Review

Ranajit Roy

Senior Medical Writer

Ranajit Roy is a Senior Medical Writer with 9 years of experience specializing in patient narratives, Clinical Evaluation Reports (CERs/CEPs), and quality review of clinical study reports (CSRs). He leads cross-functional documentation projects end-to-end, collaborating with sponsors, mentoring writers, and ensuring high-quality, compliant deliverables across multiple therapeutic areas

Adverse Event Narratives

CER/CEP Authoring

Compliance Documentation

CSR QC Review

Database Management

Leadership & Client Coordination

MS Office

Narrative Authoring & QC

Protocol/Amendment Review

QC Review

Vedant More

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.

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

+2 More

SHARED EXPERIENCES

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COO, Growth-Stage Biotech

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Clinical Data Manager

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Medical Writer

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Biostatistician

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Data QC Specialist

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Arjun Mehta

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Rajesh Chaturvedi

Senior Clinical Data Manager

Bioinformatics

Clinical Operations

Pharmacovigilance

+5 Other

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Contract initiated...

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Expertise

Clinical Data Manager

Medical Writer

Regulatory Specialist

Biostatistician

Data Engineer / Data Scientist

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