Nonclinical Document Specialist

Job Description

Accountabilities: Your role will involve generating quality nonclinical 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: Expertise in using Document Management Systems gained in a pharmaceutical environment, e.g., Veeva Vault Experience in understanding nonclinical dossier structures and advanced knowledge of common file formats and related publishing tools (e.g., ISI Toolbox, Adobe Acrobat, eCTDXPress) Knowledge of regulatory authorities requirements on electronic submissions in several regions (e.g., US, Europe, etc.) 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 with simplifying processes through automation (e.g., with Power Automate) Experience working in cross-functional, global project teams 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 (house-style), and related suites Familiarity with working within SharePoint Basic knowledge of information management and document management tools and best practices Bachelor s degree or equivalent industry-relevant experience Desirable Skills/Experience 3-5 years of industry experience in validated electronic document 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 ISI tools (e.g., ISI toolbox) Experience as SharePoint site owner