Senior Documentation Quality Lead — Regulatory Submissions

Skilled – Recruitment Solutions GmbH; Basel; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

Skilled – Recruitment Solutions GmbH is seeking a Senior Documentation Quality Specialist to ensure rigor across clinical, nonclinical, and regulatory documents within global development programs. The role emphasizes clarity, regulatory compliance, and governance of templates and standards.

The ideal candidate has a Master’s degree in life sciences with 10+ years in QA, regulatory writing, or medical editing, and strong English proficiency for cross-functional collaboration with health

Qualifikationen

• 10+ years of progressive experience in clinical/nonclinical quality assurance, regulatory writing, medical editing, or specialized document QC.
• Comprehensive understanding of regulatory submission requirements, data standards, and quality management frameworks.
• Proven ability to analyze and interpret complex clinical data, study designs, and statistical outputs.
• Superior interpersonal and communication skills across matrixed teams and external vendor networks.
• Native-level or advanced professional proficiency in English.

Aufgaben

• Audit clinical, regulatory, and nonclinical documents for accuracy, conciseness, structural integrity, source data verification, and alignment with internal protocols, templates, ICH guidelines, and global health authority mandates.
• Validate document suitability for high-stakes regulatory submissions (including NDA, MAA, and IND filings).
• Collaborate with primary authors and cross-functional partners to drive high standards of documentation quality.
• Drive the creation, enhancement, and governance of documentation templates, authoring guidelines, and quality standards.
• Direct external documentation quality specialists, overseeing task assignment, performance metrics, and deliverable timelines.
• Provide functional coaching and mentorship to peers and external partners specializing in quality control workflows.

Kenntnisse

Regulatory writing

Quality assurance

Medical editing

Documentation quality

Project management

English proficiency

Ausbildung

Master’s degree in life sciences or related discipline

Jobbeschreibung

Skilled – Recruitment Solutions GmbH is seeking a Senior Documentation Quality Specialist to ensure rigor across clinical, nonclinical, and regulatory documents within global development programs. The role emphasizes clarity, regulatory compliance, and governance of templates and standards.

The ideal candidate has a Master’s degree in life sciences with 10+ years in QA, regulatory writing, or medical editing, and strong English proficiency for cross-functional collaboration with health