Senior Medical Writer - Content Quality Review

gsk; Bengaluru; Hybrid; INR 2,800,000 - 5,200,000; Full time

Job summary

GSK is seeking an experienced QC professional to audit complex regulatory documents, ensuring data integrity and alignment across trials and submissions. The role emphasizes thorough data checks, AI-content scrutiny, and adherence to ICH/GCP guidelines.

You will collaborate with medical writers and regulatory teams, lead QC planning for studies, and mentor new reviewers. The hybrid role is based in India, with opportunities to improve processes and automation.

Qualifications

• Bachelor's or master's degree in Life Sciences / Pharmacy / Biomedical Sciences.
• 5 years and above content QC experience in the pharmaceutical industry.

Responsibilities

• Perform in-depth checks of alignment between text, tables, listings, figures, and statistical outputs, verifying support for conclusions.
• Ensure coherent, data-supported messages across related documents within a study.
• Apply regulatory SOPs and templates to ensure compliance across documents.
• Review deliverables against quality KPIs and propose solutions.
• Drive consistency of lean authoring standards and data presentation across document types.
• Interpret and summarize complex scientific data used in regulatory documents.
• Collaborate with medical writers, clinical, and regulatory colleagues to resolve content issues and provide constructive feedback.
• Lead and own project-level QC planning and delivery.
• Provide coaching to new QC reviewers and contribute to process improvements.
• Ensure QC processes are inspection-ready and explore automation opportunities.

Skills

Content QC expertise

Regulatory documents understanding

AI content review

MS Word proficient

Excel

PowerPoint

SharePoint

Document management systems

Problem solving

ICH/GCP knowledge

Collaboration without authority

Regulatory messaging alignment

Education

Bachelor's or Master's in Life Sciences / Pharmacy / Biomedical Sciences

Tools

MS Word

Excel

PowerPoint

PDF tools

SharePoint

Document management systems

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.
Find out more:
Our approach to R&D

Position Summary

An experienced individual contributor responsible for QC of complex and high-impact clinical and regulatory documents, providing content and data review, ensuring scientific sense checks, driving and owning QC consistency and compliance across various document types and therapeutic areas.

Key Responsibilities

• Perform in-depth checks of alignment between text, tables, listings, figures, and statistical outputs, identifying subtle inconsistencies, gaps, or potential misinterpretations, and assess whether conclusions and key messages are fully supported, including checks on AI-assisted or AI-generated content.
• Ensure coherent, aligned, and data-supported messages across related documents within a study.
• Apply a robust understanding of regulatory expectations, internal SOPs, and templates to ensure compliance across documents, and application or optimisation of templates, as needed.
• Review deliverables against standard quality KPIs; proactively identify quality and compliance risks and propose solutions, escalating issues where appropriate; use judgement and discretion to resolve complex QC issues, communicate findings clearly.
• Drive consistency of lean authoring standards, language, editorial aspects, terminology, and data presentation across document types; including cross-document alignment with clinical/regulatory messaging.
• Able to interpret and summarize complex scientific and clinical data commonly used in regulatory documents, assessing whether conclusions and key messages are fully supported.
• Partner with medical writers, clinical, and regulatory colleagues to resolve content and data issues; influence without formal authority, providing clear, constructive reasoning/feedback while maintaining strong collaborative relationships.
• Lead and own project-level QC planning and delivery independently.
• Provide coaching to new QC reviewers, as needed; lead or significantly contribute to quality, automation, and process‑improvement initiatives to drive acceleration and first‑time‑right quality.
• Ensure QC processes and documentation are inspection‑ready, consistent, and traceable; demonstrate digital fluency with GxP compliant QC and authoring tools and identify opportunities to automate routine QC checks; and stay current with evolving technology and industry trends, translating into actionable ways of working for the team

Basic Qualification

• Bachelor's or master's degree in Life Sciences / Pharmacy / Biomedical Sciences:
  5 years and above content QC experience in the pharmaceutical industry.

Other Job-Related Skills

• Deep understanding of clinical development, study design elements, and the landscape of regulatory documents (e.g. CSRs, protocols, IBs, clinical summaries/overviews).
• QC mastery of key regulatory document types; able to manage QC on at least 2 documents or projects simultaneously.
• Medical writing experience in patient 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.
• AI literacy and digital proficiency: able to critically assess AI-assisted or AI-generated content, use structured content management and content review platforms.
• Strong problem‑solving and critical‑thinking skills, anticipating issues/risks and proposing effective solutions/mitigations.
• Possesses a strong understanding of drug development and working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
• Influences without authority, role‑models continuous improvement, proactively shares knowledge and supports the development of the broader team.
• Seeks opportunities to expand knowledge of regulatory medical writing and QC practices and drives own development plan

Working Model

This role is hybrid, based in India. You will spend core days in the office for collaboration and use flexible remote working for focused review and writing.

Why GSK?

Unite 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.