Nonclinical Document Specialist

AstraZeneca · Cambridge, UK

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Clinical OperationsFull-timeCompany career page

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Role summary

AstraZeneca seeks a Nonclinical Document Specialist in Cambridge to manage regulatory submission documentation and archival data for clinical and marketing applications. The role involves preparing compliant nonclinical dossiers, coordinating with cross-functional teams, and maintaining submission records according to regulatory standards.

What they're looking for

Knowledge of nonclinical dossier structures and regulatory submission formats
Experience with electronic document management systems in pharmaceutical settings, such as Veeva Vault
Proficiency in Word, Excel, Adobe Acrobat, ISI Toolbox, and eCTDXPress
Understanding of regulatory authority requirements for electronic submissions across regions
Knowledge of CTD formatting standards, GXP principles, and ICH guidelines
Strong written and verbal communication with demonstrated ability to manage priorities
Bachelor's degree or equivalent industry experience

What you'll be doing

Generate nonclinical submission documents and structures meeting regulatory-authority requirements
Create and edit regulatory submission documents, including literature references and reference lists
Apply compliant naming conventions and ensure submissions meet house-style and agency standards
Maintain and prepare submission document templates for ongoing use
Support archival data handling and ensure accuracy, completeness, and consistency of records

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