Nonclinical Document Specialist
Core
Ensure technical quality and delivery of nonclinical regulatory submissions for clinical trial and marketing applications.
Role type
Nonclinical Document Specialist
Builds
Regulatory submission documents (dossiers) for clinical trials and marketing applications
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Nonclinical dossier structures, electronic document management systems (Veeva Vault), regulatory authority requirements (US, Europe), GXP/ICH principles, CTD content and formatting, Microsoft Office (Word, Excel), SharePoint, process automation (Power Automate)
Preferred skills
Drug development process knowledge, CFR21 part 11 requirements, Adobe Acrobat, database tools, SharePoint site ownership
Technologies
Veeva Vault, ISI Toolbox, Adobe Acrobat, eCTDXPress, Power Automate, SharePoint, Microsoft Office
Responsibilities
Generate quality nonclinical basic structures and content for regulatory submissions, import and create documents including referenced literature, edit submission documents for house-style and regulatory compliance, maintain submission document templates, manage archival data and records with attention to detail and metadata quality
Seniority
Mid-level, hands-on IC
