Nonclinical Document Specialist
Nonclinical Document Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Title: Nonclinical Document Specialist
Introduction to role:
Are you ready to embrace new and varied opportunities to develop and learn As a Nonclinical Document Specialist youll be part of the Nonclinical Submission group responsible for ensuring the technical quality and timely delivery of all nonclinical submissions. Youll provide expert advice on nonclinical submission technical requirements to project teams including both internal and external partners throughout the lifecycle of a product. This is your chance to build nonclinical regulatory submissions for clinical trial and marketing applications in accordance with current standards and processes using agreedupon tools. Are you ready to make an impact
Accountabilities:
Your role will involve generating quality nonclinical structures and content for regulatory submissions ensuring relevant regulatoryauthority 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 housestyle AstraZenecas submissionready 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 crossfunctional 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 (housestyle) and related suites
Familiarity with working within SharePoint
Basic knowledge of information management and document management tools and best practices
Bachelors degree or equivalent industryrelevant experience
Desirable Skills/Experience
35 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
When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca we fuel ambition and break new ground with our growing BioPharmaceuticals pipeline. Our forwardlooking approach allows us to see the world through a different lens connecting science with technology to find solutions that impact patients lives. We thrive in a vibrant environment filled with diversity that reflects the variety of patients we serve. Here everyone is empowered to speak up and share ideas fostering an inclusive atmosphere where alternative perspectives push our thinking further. With ample opportunities for continuous learning and career growth AstraZeneca is committed to enhancing patient care for the future.
Ready to make your mark Apply now and be part of our journey!
Date Posted
09May2025Closing Date
22May2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industryleading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
