Job Description

CAREER LEVEL: D
Lead the way for a new breed of solutions-oriented Regulators
Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development
Be part of the team where you are empowered to follow the science
Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..

ABOUT ASTRAZENECA
At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development

ABOUT THE TEAM
We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.

ABOUT THE ROLE
Enterprise Regulatory Vault (ERV) is AstraZeneca\'s business-wide system for Regulatory Information Management (RIM). As a data-centric cloud / SaaS platform it enables compliance with current regulatory requirements and can evolve to meet future needs. This flexibility brings many benefits, but also the key challenge of a relentless cycle of incremental and continual changes that requires ongoing investment of time and resources to ensure AZ maximizes utility and enables automation, digitization and agility to meet future needs.

An organisation within GRO exists specifically to manage these key systems (and their associated standards and processes) on behalf of the cross-functional business, ensuring that they are

• Effectively maintained, developed and supported to meet the needs of the business.
• Administered, accessed and used in accordance with AZ policy and Health Authority requirements

The Manager, Regulatory Information Management Systems plays a key role in supporting the RIM suite of tools, and applies specialized knowledge relating to ensuring that customers gain full value from available information assets.
Typical Accountabilities

• Providing expert system-related guidance and business support to users [both internal to AZ and external partners] through personal interaction and online ticket management systems
• Working with product owners, business teams and process owners to develop and support business processes pertaining to our RIM platform
• Business administration of systems, e.g. provision of system access, maintenance of master data, application of security models and managing change
• Development of training and user support materials, e.g. job aids, training videos, e-learning
• Management of systems communication methods, e.g. SharePoint, OneNote, MS Teams, Workplace.
• Writing scripts and participating in system testing in support of system releases
• Facilitating and acting as the link between business and IS support
• Cross-training to learn a growing number of systems, taking on additional responsibility

The successful candidate will work in a functional matrix environment, reporting to a Section Director, and taking direction from Associate Directors who manage a portfolio of work.
Education, Qualifications, Skills and Experience
Essential

• Bachelor\xe2\x80\x99s degree or a proven track record of equivalent experience within a commercial environment.
• Experience of business administration for a validated application within a regulated environment, preferably within the pharmaceutical industry.
• Experience of delivering business support and/or training to end users.
• Fluent in written and verbal English.

Desirable

• Knowledgeable in the drug development process, including regulatory documentation, submission, publishing and approval processes
• Experience of working with an enterprise-wide Document Management System and/or other Regulatory tools supported by GRO (e.g. publishing software, tracking databases).
• Ability to build relationships across, cultures, functions and disciplines to deliver a quality service
• Key capability requirements:

o Building relationships across, cultures, functions and disciplines to deliver a quality service
o Excellent interpersonal skills
o Delivery and customer focused
o Good organizational skills

WHY JOIN US?
We believe there\xe2\x80\x99s always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.
Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to make valuable contributions throughout

SO, WHAT\xe2\x80\x99S NEXT?
Are you already envisioning yourself joining our team? Good, because we\xe2\x80\x99d love to hear from you! Click the link to apply and we\xe2\x80\x99ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
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.