Senior Documentation Quality Specialist

Flexsis; Allschwil; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Flexsis is seeking an experienced Senior Documentation Quality Specialist to ensure the highest quality of clinical, nonclinical, and regulatory documentation. You will act as a subject matter expert, guiding authors and cross-functional partners to deliver accurate, compliant, and submission-ready documents for health authority interactions and global regulatory submissions.

Ideal candidates hold a Master’s degree in science, 10+ years in QA/writing, and expert knowledge of regulatory

Qualifikationen

• 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.

Aufgaben

• Review clinical, regulatory, and nonclinical documents for clarity, conciseness, consistency, completeness, alignment with source data, and compliance with internal procedures, templates, ICH guidance, and health authority requirements.
• Ensure documents are suitable for inclusion in regulatory submissions (NDA, MAA, IND).
• Partner with authors and cross-functional stakeholders to improve document quality.
• Contribute to templates, guidelines, standards, and best practices for documentation.
• Coordinate with external documentation quality specialists, including work allocation and timely delivery of outputs.
• Coach and mentor external consultants and colleagues in documentation quality control.
• Support due diligence activities when required.

Kenntnisse

Attention to detail

Communication skills

Interpersonal skills

Independent work

Prioritization

English proficiency

Ausbildung

Master’s degree in science

Jobbeschreibung

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.