Principal Medical Writer - Content Quality Review

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 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.