Principal Medical Writer - Content Quality Review (India)

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D; focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform peoples lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. Were uniting science, technology, and talent to get ahead of disease together.

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Position Summary

An expert individual contributor who leads content QC of complex, pivotal clinical and regulatory documents and submissions across therapeutic areas, ensuring in-depth content and data review, scientific sense checks, lean authoring review, and setting future fit QC standards being a subject matter expert for medical writing and clinical teams with demonstrated digital fluency working and implementing AI-assisted QC or automated content generation tools and platforms.

Key Responsibilities

• Lead QC for complex, pivotal clinical and regulatory documents and submissions (e.g. CSRs, integrated summaries, health authority responses, briefing documents, protocols and IBs).
• Perform QC checks on alignment between text, tables, listings, figures, and statistical outputs, resolving high-risk inconsistencies, gaps, or potential misinterpretations, and confirming that conclusions and key messages are supported by the data.
• Perform scientific sense-checks to ensure coherent, aligned, and data-supported messages across a submission package, spanning multiple studies and document types.
• Own and improve QC checklists, templates, and technical standards used to assess document quality, applying regulatory and scientific expertise to keep them current and fit for purpose.
• Identify quality and compliance risks and drive solutions and CAPA; support audit and inspection readiness for complex documents/submissions.
• Lead lean authoring standards, editorial quality, and data interpretation/presentation across document types, including cross-document alignment with clinical and regulatory messaging.
• Support project management by delivering QC commitments to a high standard and on schedule.
• Represent content QC in process-improvement discussions, functional knowledge-share sessions, audits, and health authority interactions.
• Support technical quality oversight of externally delivered (FSP/vendor) content.
• Build QC capability by establishing strong training and onboarding standards that prepare the team for evolving, transformative authoring and review practices; develop and deliver QC training content incorporating industry standards for medical writing and QC competency.
• Review MW and QC quality against quality KPIs and drive interventions, as needed.
• Lead the evaluation and adoption of AI-assisted and automated QC and authoring tools, ensuring GxP-validated platforms are identified, tested, and implemented.

Basic Qualification

Master's degree or PhD in Life Sciences / Pharmacy / Biomedical Sciences

8 years and above of content QC experience in the pharmaceutical industry, including experience leading pivotal regulatory submissions.

Other Job-Related Skills

• Proven expertise in clinical and safety documents (CSRs, protocols, IBs, clinical summaries, RMPs, regulatory submissions).
• QC mastery across most regulatory document types; able to lead QC simultaneously on multi-document, complex CTD submissions.
• Medical writing experience in narratives and clinical documents.
• Advanced proficiency in MS Word and high competence in other relevant tools (Excel, PowerPoint, PDF tools, SharePoint, document management systems), including effective use of advanced review features.
• Skilled communicator, able to offer solutions to complex quality scenarios; serves as a SME who builds credibility and effective relationships across global teams and stakeholders.
• Strong problem-solving and critical-thinking skills, anticipating issues/risks and proposing effective solutions/mitigations.
• Deep working knowledge of regulatory guidelines (ICH E3, E6, GCP) and their application.
• Works under broad direction, demonstrates strong leadership at an individual level, and takes accountability for delivering significant outcomes.
• Proactively keeps up with industry and technology developments in medical writing/content QC and drives own development plan.

Ready to apply

If this role matches your skills and ambition, we would love to hear from you. Please submit your CV and a short note explaining your interest and relevant experience. Join us to help get ahead of disease together.

Skills

Why GSK

Uniting science, technology and talent to get ahead of disease together.

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