Nonclinical Document Specialist
HybridBengaluru, Karnataka, India
Job Summary
Manage nonclinical data archival, coordinate urgent requests, and ensure chain of custody for primary raw data and critical biological specimens. Edit submission documents to meet AstraZeneca's house-style, regulatory agency requirements, and CTD standards while maintaining accurate indexing and metadata quality. Contribute to submission document content plans and templates, providing technical advice to internal and external partners throughout the product lifecycle. Support archive-related processes and database oversight to ensure accuracy, completeness, and consistency of records in validated electronic document management systems.
Required Qualifications
- Good understanding of records management, or document control principles, with the ability to apply these in a regulated or process-driven environment
- Experience of maintaining accurate records within archive or data management systems, with strong attention to detail and data quality, including accurate indexing, metadata quality, traceability, and retrieval requirements
- Highly developed influencing skills and interactive communication when interacting with people at all levels and within teams
- Demonstrated ability to set and manage priorities, resources, goals and project initiatives
- Demonstrated strong written and verbal communication skills, with the ability to provide clear updates, manage queries professionally, and build effective working relationships across cross-functional, geographically dispersed global teams and matrix structures
- Awareness of basic principles of GXP and ICH (International Conference on Harmonization)
- Basic understanding of CTD (Common Technical Document) content and formatting standards to ensure submission compliant documentation
- Proficiency in Microsoft Office, particularly Microsoft Word and Excel (editing, data handling), and related suites
- Familiarity with working within SharePoint
- Experience with simplifying processes through automation (e.g., with Power Automate)
- Experience working within validated electronic document management systems in a pharmaceutical environment, e.g., Veeva Vault
- Bachelor's degree or equivalent industry-relevant experience
Desired Qualifications
- 3-5 years of industry experience in validated electronic data management systems
- Knowledge of the basic principles of the drug development process
- Basic understanding of principles of CFR21 part 11 requirements and other global standards
- Experience with Adobe Acrobat and related database tools
- Experience in understanding submission dossier structures and advanced knowledge of common file formats and related publishing tools (e.g., ISI Toolbox, Adobe Acrobat, eCTDXPress)
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