Job 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

- Masters 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 regulatory document types, 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Principal Medical Writer - Content Quality Review (Bengaluru)
🏢 GSK India
📍 Bengaluru