Content Publishing Manager ensuring regulatory-ready outputs in clinical documentation at GSK. Leading publishing expertise and driving excellence across technical compliance and publishing domains.
Responsibilities
Act as a senior technical expert for publishing and compliance QC of clinical and regulatory documents.
Demonstrate advanced proficiency in Veeva Vault including workflow optimisation, troubleshooting, and integration with other tools.
Lead quality assessments to ensure all outputs meet GSK standards and compliance expectations.
Independently plan, prioritise, schedule, and track a multi-document delivery pipeline.
Maintain operational oversight through milestone tracking, throughput measurement, and submission delivery planning.
Serve as process owner for key publishing tasks and collaborate to refine global processes.
Monitor and maintain operational and quality KPIs with periodic assessments and tracking.
Act as a key technical liaison between medical writing and cross-functional teams.
Requirements
Master’s degree in pharmacy, Life Sciences, Biomedical Science, or equivalent scientific discipline.
8+ years of experience in medical writing/clinical document publishing or regulatory publishing within pharma/biotech R&D.
Strong knowledge of regulatory guidelines, SOPs, and eCTD publishing standards.
Hands-on publishing of CSRs, Protocols, IBs, and Module documents to meet global regulatory standards.
Practical, advanced document level publishing experience within Veeva Vault.
Managing complex publishing pipelines, forecasting workloads, and meeting regulatory timelines without direct supervisory authority.
KPI and dashboard development, operational analytics, and performance reporting.
Strong stakeholder and vendor engagement experience in a global, matrixed environment.
Strong communication and analytical and problem-solving capability with attention to detail.
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