Nonclinical Document Specialist

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 worlds most serious diseases. But were more than one of the worlds 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 youll 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. The role also includes handling of archival data and supporting the accuracy completeness and consistency of records. 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 AstraZenecas submission ready standards and regulatory agency requirements. You will also contribute to the preparation and maintenance of submission document templates.

Essential Skills/Experience:

• 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.)
• Experience working within validated electronic document management systems in a pharmaceutical environment e.g. Veeva Vault
• 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 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.
• 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)
• Bachelors 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 as SharePoint site owner

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person 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.

Why AstraZeneca

At AstraZenecasBiopharmaceuticals R&D we are part of thesolution turning our drug developmentstrategies into reality. We work at allstages of development to translate ourlife-changingscience 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 differentskills and experiences. Our differences enableus to explore new ideas and ways of doing things. It keepsus on our toes and excited for whatsnext.

Where Can I Find Out More

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Ready to make a difference Apply today and be part of our journey to createlife-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