Nonclinical Document Specialist
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. 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:
- Expertise in using Document Management System gained in a pharmaceutical environment, eg, Veeva Vault
- 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.)
- 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 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
- Experience working within validated electronic document management systems
- 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.
Why AstraZeneca?
At AstraZeneca's Biopharmaceuticals R&D, we are part of the solution, turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next.
Ready to make a difference? Apply today and be part of our journey to create life-changing medicines!
*Please apply with your resume written in English
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.
