Senior Medical Writer - Content Quality Review

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

• Bachelors or Masters 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 Conference 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.