Senior Regulatory and Clinical Documentation Expert

The Senior Documentation Quality Specialist acts as an enterprise Subject Matter Expert (SME), ensuring maximum rigor across clinical, nonclinical, and regulatory documentation. This position is accountable for the clarity, precision, structural consistency, and regulatory compliance of critical assets across global development programs, health authority engagements, and submission dossiers.

• Rigorously 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.

• Master’s degree or equivalent in a life sciences or related discipline.
• 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.
• Demonstrated precision, analytical rigor, and project management skills within time-critical environments.
• Superior interpersonal and communication skills across matrixed teams and external vendor networks.
• Native-level or advanced professional proficiency in English.

Proven track record within Documentation Quality, Regulatory Writing, Medical Writing, Clinical Documentation, Regulatory Operations, or QA in the pharmaceutical or biotechnology sectors. Hands-on experience delivering submission-critical dossiers to health authorities is essential.

• Strategic influence as a recognized SME shaping submission success.
• Ownership of operational quality standards with the opportunity to streamline documentation practices.