INT-122109
Senior Documentation Quality Specialist
Basel
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Pharmaceutical / Biotechnology / Chemical
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Temporary full time
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.
Description of the mission
- 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.
Required profile
- 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.
Your contact
- home FLEXSIS - BASEL LIFESCIENCE
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