Principal Medical Writer - Content Quality Review

GlaxoSmithKline; Bengaluru; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

GSK in Bengaluru, India, is seeking an expert content QC professional who leads QC of pivotal clinical and regulatory documents, with AI-assisted tool experience to raise standards across therapeutic areas. You will ensure text, tables and figures align, manage risk, and drive training to build a next‑gen QC capability for medical writing and submissions.

The role requires a Master’s or PhD in life sciences and 8+ years in pharmaceutical content QC, with strong regulatory and cross‑functional

Qualifications

• Expert in clinical and safety documents (CSRs, protocols, IBs, summaries, RMPs, submissions).
• QC mastery across regulatory document types; lead multi‑document CTD submissions.
• Medical writing experience in narratives and clinical documents.
• Advanced Word skills; proficient in Excel, PowerPoint, PDFs, SharePoint, DMS.

Responsibilities

• Lead QC for complex clinical and regulatory documents and submissions.
• Perform QC checks aligning text, tables, listings, figures with data.
• Perform scientific sense-checks across submission packages.
• Own and improve QC checklists, templates and standards.
• Identify QA risks and support audits/inspections readiness.
• Lead lean authoring standards and cross-document alignment.
• Support project management and deliver QC on schedule.
• Represent content QC in process improvements and audits.
• Support external vendor content QC.
• Build QC capability through training and onboarding.
• Review MW and QC quality against KPIs.
• Lead adoption of AI-assisted QC tools.

Skills

Medical writing

Quality control

Regulatory submissions

Leadership

Education

Master's or PhD in Life Sciences

Tools

MS Word

Excel

PDF tools

SharePoint

Job description

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 people’s 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.

We’re uniting science, technology, and talent to get ahead of disease together.

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 efficient 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.

Why GSK?

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.

We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.

We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.

Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Inclusion at GSK

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [e-mail] to discuss your needs.