PHARMAFull-time
Nonclinical Document Specialist
BANGALORE (IN)HYBRIDPOSTED: 8/13/2026
PHARMAFull-time
HIRING ORGANIZATIONASTRAZENECAPharmaceuticals / Biopharmaceuticals / Healthcare
ROLE DEFINITION & RESPONSIBILITIES
Manage nonclinical data archival, technical quality, chain of custody, and primary raw data/specimen repository operations.
Edit and format nonclinical submission documents to ensure conformance with house style, submission-ready standards, CTD formats, and regulatory agency requirements.
Maintain record indexing, metadata quality, and electronic document management systems (EDMS) for nonclinical regulatory dossiers.
Support the preparation of submission document content plans, templates, and automated workflows using tools like Power Automate.
Collaborate cross-functionally across global matrix project teams to provide guidance on nonclinical submission technical requirements.
REQUIRED VERIFIED SKILLS
Document Control
Records Management
Electronic Document Management Systems (EDMS)
Nonclinical Data
Microsoft Word
CTD Formatting
GxP
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines. The company operates in various therapeutic areas, including Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. AstraZeneca is committed to pushing the boundaries of science to deliver life-changing medicines and improve patient outcomes worldwide.
TEAM SIZE: 89,000+ employees
INDUSTRY: Pharmaceuticals / Biopharmaceuticals / Healthcare
RECOMMENDED TRAINING
1/4
READY TO SUBMIT?
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