Nonclinical Document Specialist

Job Title: Nonclinical Document Specialist

Career Level - C

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. 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 Systems 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 and related suites

• 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

• 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's Oncology R&D department, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It's science with an impact-making a difference for patients and people around the world.

Are you ready to make a meaningful difference in the world of Oncology? Apply now and join us in our mission to eliminate cancer as a cause of death!