Senior Documentation Quality Specialist

Our client is seeking an experienced Senior Documentation Quality Specialist to act as a subject matter expert for the quality of clinical, nonclinical, and regulatory documentation. The role ensures that key deliverables are clear, accurate, consistent, compliant, and submission-ready, supporting development programmes, health authority interactions, and global regulatory submissions. - Review clinical, regulatory, and nonclinical documents for clarity, conciseness, consistency, completeness, alignment with source data, and compliance with internal procedures, templates, ICH guidance, and relevant health authority requirements. - Ensure documents are suitable for inclusion in critical regulatory submissions, including NDA, MAA, and IND dossiers. - Partner with authors, contributors, and cross-functional stakeholders to continuously improve the quality of clinical and regulatory documents. - Contribute to the development and implementation of documentation templates, guidelines, standards, and best practices. - Manage collaboration with external documentation quality specialists, including work allocation, quality oversight, and timely delivery of outputs. - Coach and mentor external consultants and colleagues developing expertise in documentation quality control. - Support due diligence activities when required. - Master’s degree or equivalent qualification required; a science-related discipline is preferred. - At least 10 years of relevant experience in clinical and/or nonclinical quality assurance, medical or regulatory writing, or the editing and quality review of clinical and nonclinical documents. - Strong knowledge of regulatory documentation requirements, guidelines, submission standards, and document quality expectations. - Good understanding of experimental methods, research design, and statistical analysis. - Ability to analyse and interpret medical data generated in clinical trials. - Excellent attention to detail, accuracy, judgement, and quality orientation. - Ability to work independently, manage priorities, and deliver effectively within tight timelines. - Excellent communication and interpersonal skills, with confidence working across functions and with external partners. - Advanced proficiency in English.