Nonclinical Data

AZ are looking for a Nonclinical data & document manager/admin to provide support in both nonclinical CDISC standards and document management to support nonclinical submissions. The role will cover a range of activities relating to both, with development opportunities to expand knowledge on Nonclinical data and submission standards.

**Major Duties and Responsibilities**:
Being part of the Nonclinical Submissions group, you will have the opportunity to work with colleagues in a number of different roles within the organisation and have the prospect for long term career development. A key role is to ensure the Submissions Team’s ability to adhere to tight timelines and deliver critical documents/data required to get our medicines to patients.
- Provide support to the SEND team through effective workload planning, ensuring SEND deliveries are met for submission deadlines
- Maintaining the SENDTrax planning board, implementing any improvements as deemed necessary
- Work with external SEND teams, as well as internal project teams, to plan for SEND deliverables
- Opportunity to develop knowledge of SEND, with views to support SEND data reviews from CROs and internal SEND generation processes

**Required Skills/Experience**:

- Awareness of basic principles of GXP/ICH and PhUSE guidelines
- 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
- Expertise in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint, OneNote, Skype for Business, SharePoint online).
- Demonstrated ability to set and manage priorities, resources, goals and project initiatives.
- Basic knowledge of information management and document management tools and best practices.
- Knowledge of CDISC standards is desirable.
- Good planning/time management and interpersonal skills
- Understanding of non-clinical study designs, data and documentation (e.g. plan/protocol, study schedules, deviations, drafts and final reports)
- **_ Education: _**Bachelor’s degree (B.A./B.S.) or equivalent in a scientific or related discipline.
- **_ Experience: _**Three to Five years related experience in a scientific environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

**Desirable requirements**
- Experience in using Document Management System gained in a pharmaceutical environment, e.g. Documentum/Veeva
- Familiarity with nonclinical dossier structures and related publishing tools (e.g. ISI Toolbox, Adobe Acrobat)
- Knowledge of regulatory authorities’ requirements on electronic submissions in several regions (e.g. US, Europe, etc.).