Nonclinical Document Specialist

Job Title: Nonclinical Document Specialist

Global Career Level: C

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we 're dedicated to being a Great Place to Work. 

ABOUT THE ROLE

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, repository and delivery of all nonclinical data (primary raw data and critical biological specimens) and data for non-clinical submissions. You will coordinate and manage data archival, 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 work with data for nonclinical regulatory submissions for clinical trial and marketing applications in accordance with current standards and processes using agreed upon tools.

Accountabilities:

For primary raw data, the role would focus on supporting archive-related processes, managing requests, coordinating urgent requirements, and maintaining effective communication across stakeholders, ensuring that all relevant forms, chain of custody requirements, and internal delivery arrangements are properly managed through operational processes. The role also includes oversight of archival data management within the database, supporting the accuracy, completeness, and consistency of records held in internal databases or other relevant archive management systems. For non-clinical documents, 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 content plans and templates.

Essential Skills/Experience:

- Good understanding of records management, or document control principles, with the ability to apply these in a regulated or process-driven environment.

- Experience of maintaining accurate records within archive or data management systems, with strong attention to detail and data quality, including accurate indexing, metadata quality, traceability, and retrieval requirements.

- 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

- Demonstrated strong written and verbal communication skills, with the ability to provide clear updates, manage queries professionally, and build effective working relationships across cross-functional, geographically dispersed global teams and matrix structures.

- 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 and Excel (editing, data handling), and related suites

- Familiarity with working within SharePoint

- Experience with simplifying processes through automation (e.g., with Power Automate)

- Experience working within validated electronic document management systems in a pharmaceutical environment, e.g., Veeva Vault

- Bachelor’s degree or equivalent industry-relevant experience

Desirable Skills/Experience:

- 3-5 years of industry experience in validated electronic data 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 database tools

- Experience in understanding submission dossier structures and advanced knowledge of common file formats and related publishing tools (e.g., ISI Toolbox, Adobe Acrobat, eCTDXPress)

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' Biopharmaceuticals R&D, we are part of the olution, turning our drug development trategies into reality. We work at all tages of development to translate our ife-changing cience 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 kills and experiences. Our differences enable s to explore new ideas and ways of doing things. It keeps s on our toes and excited for what' next.

Where Can I Find Out More?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Call to Action:

Ready to make a difference? Apply today and be part of our journey to create life-changing medicines!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.