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Mukta Sharma

@muktasharma

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Regulatory medical writer specializing in safety documents and clinical submissions.

India

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What I'm looking for

I seek a role in regulatory medical writing or pharmacovigilance where I can author high-quality clinical documents, mentor junior writers, improve processes, and contribute to compliant, timely regulatory submissions in a collaborative team.

I am a detail-oriented Regulatory Medical Writer with around 5 years of pharmaceutical industry experience, focused on authoring and reviewing high-quality clinical and regulatory documents.

I have authored and reviewed over 800 regulatory and clinical documents including >50 Clinical Study Reports, >25 Clinical Protocols, >500 Safety Narratives, and multiple CTD dossier module submissions across Oncology, Respiratory, Infectious Diseases, Vaccines and other therapy areas.

I am proficient with ICH guidelines and regulatory submission requirements (FDA, EMA), and experienced in cross-functional collaboration with clinical, biostatistics, and regulatory affairs teams. IQA-certified trainer for regulatory document quality checks and experienced in calibration activities to ensure consistent quality standards.

I seek to drive process improvements, mentor new writers, and ensure timely, compliant delivery of clinical documents using tools such as Veeva Vault, EndNote and other regulatory-authoring and review platforms.

Experience

Work history, roles, and key accomplishments

Current

Assistant Manager

Current

Tata Consultancy Services

Jan 2023 - Present (2 years 10 months)

Author and review clinical and regulatory documents (CSRs, IBs, protocols, CTD summaries), perform quality checks to ensure SOP and regulatory compliance, and lead project timelines and training initiatives; authored/reviewed 800+ documents including >50 CSRs and >500 safety narratives.

Regulatory Writing CTD Pharmacovigilance ICH Guidelines

Associate Scientist

AarogyaAI Innovations Pvt. Ltd.

Jan 2022 - Jul 2022 (6 months)

Applied diverse computational modelling approaches to identify novel chemical entities for TB drug discovery and supported lead identification workflows.

Computational Models Drug Discovery QSAR Python Molecular Docking Bioinformatics

Postdoctoral Researcher

The University of Chicago

Apr 2018 - Nov 2019 (1 year 7 months)

Used computational approaches to study protein kinase activity probes, elucidating binding mechanisms and reactivity to inform probe design and biochemical interpretation.

Molecular Dynamics Data Analysis Python NAMD GROMACS

Research Associate

CSIR-Institute of Genomics and Integrative Biology

Sep 2016 - Aug 2017 (11 months)

Developed a systems-biology virtual drug discovery model to predict non-toxic metabolic targets in Mycobacterium tuberculosis and supported computational target identification.

Bioinformatics literature review Data Analysis

Pharmacovigilance Scientist

Parexel International

Apr 2015 - Aug 2016 (1 year 4 months)

Authored and reviewed aggregate safety reports (PADERs, PSURs, PBRERs), prepared RMPs, performed literature searches and triage, and ensured timely medical evaluation of adverse event information.

Pharmacovigilance Aggregate Safety Reports PBRERs PSURs Safety Narratives Triage