Nonclinical Document Specialist

ABOUT ASTRAZENECAAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. ABOUT

THE ROLE Introduction to role

Are you ready to embrace new and varied opportunities to develop and learn? As a Nonclinical Document Specialist, you’ll work as a member of the Nonclinical Submission group with accountability for the technical quality and delivery of all nonclinical submissions. You will provide advice on nonclinical submission technical requirements to project teams, including internal and external partners, throughout the lifecycle of a product.

The role also includes handling of archival data and supporting the accuracy, completeness and consistency of records. This is your chance to build nonclinical regulatory submissions for clinical trial and marketing applications in accordance with current standards and processes using agreed upon tools. Accountabilities:

Your role will involve generating quality and nonclinical basic structures and content for regulatory submissions, ensuring relevant regulatory-authority compliant document naming conventions are applied to components. You will import and create documents for regulatory submissions including referenced literature and reference lists. Your responsibilities will also include submission document editing, submission readiness conformance with house-style, AstraZeneca’s submission ready standards and regulatory agency requirements.

You will also contribute to the preparation and maintenance of submission document templates. Essential Skills/

Experience:

Experience in understanding nonclinical dossier structures and advanced knowledge of common file formats (eg, Word) and related publishing tools (eg, ISI Toolbox, Adobe Acrobat, eCTDXPress)
Knowledge of regulatory authorities’ requirements on electronic submissions in several regions (eg, US, Europe, etc.)Experience working within validated electronic document management systems in a pharmaceutical environment, e.g., Veeva Vault 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

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.

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 Share Point Experience  with simplifying processes through automation (e.g., with Power Automate)
Bachelor’s degree or equivalent industry-relevant experience

Desirable Skills/

Experience:

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 CFR
21 part 11 requirements and other global standards

Experi…