Typically works independently with only moderate supervision and guidance in own knowledge area. Researches and analyses internal and external information to determine methodology choices. Is able to resolve complex issues within specialised area and participates in research projects.

Typically Accountabilities

Collects reviews and tracks regulatory and other relevant documents

Initiates and maintains production of documents, ensuring template and version compliance

Creates and/or imports clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GEL

Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities

Leads administrative appendices for the CSR

Provides input into non-drug project work including training activities and development of procedures as needed

Monitors the set-up and maintenance of information in AstraZeneca tracking and communication tools (e.g. IMPACT, Clinical Partners Portal and eRoom) and support others in the usage of these systems

Manages and coordinates tracking of study materials and equipment

Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs

Leads the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors

Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites

Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Qualification

Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers

Ability to develop advanced computer skills to increase efficiency in day-to-day tasks

Proven organizational and analytical skills

Ability to prioritise and manage multiple tasks with conflicting deadlines

Excellent knowledge of spoken and written English

Good interpersonal skills and ability to work in a team environment

Excellent verbal and written communication and presentation skills

Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities

Ability to prepare presentation materials

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.