Nonclinical Document Specialist

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, you'll be part of the Nonclinical Submission group, responsible for ensuring the technical quality and timely delivery of all nonclinical submissions. You'll 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 agreed-upon tools. Are you ready to make an impact?

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're 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 forward-looking 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!

AstraZeneca 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 industry-leading 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 non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.