Job Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

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

Typical Accountabilities

• Leading a global team to achieve a specified class of activity related to RIM tools (e.g. Administration, Data Standards, User Support, Training, Authoring, Change Management, Security and Use)

• Prioritizing, organizing and coordinating activity within the GRO team, providing leadership, resource and training to others
• Analyzing queries and trends to proactively identify issues and areas for improvement
• Designing and delivering innovative business solutions to meet customer needs, agreeing the future shape of proposed solutions and managing business expectations of outcomes
• Developing and maintaining long-term plans in collaboration with GRO leaders and colleagues
• Establishing practices and written guidance/instruction to ensure quality, efficiency and timely completion of activities delivered by the assigned team.
• Establishing and managing data standards and processes to ensure effective use of RIM systems on behalf of business users

• Building strong relationships with customer groups, developing deep understanding of the current business as well as future direction; responding to changing needs and assessing and prioritizing in line with AZ and GRO strategy and expectations

• Collaborating closely with other experts in AZ who are involved in the design, development and delivery of RIM system capabilities and related business deliverables such as policies, procedures, processes and guidance

• Ascertaining industry best practice in related to RIM systems, driving implementation and standardization across the user communities, and providing strategic input into key decisions

• Advocating and influencing vendors for continuous improvement practices to ensure that RIM supports the AZ product portfolio and anticipates future business needs and industry requirements.

• Providing expertise within area of accountability to support mergers, acquisitions, divestments, offering RIM Expert advice on best practices to further support AZ strategic ambition.

• Function as subject matter expert, providing advice and analysis to AZ product teams and co-development partners on matters pertaining to RIM and cross-RIM applications and initiatives.

• Representing AZ externally in areas relevant to RIM and best practice \xe2\x80\x93 e.g. vendor forums, industry forums, collaborators, technical service partner

Education, Qualifications, Skills and Experience

Essential

Desirable * Bachelor\xe2\x80\x99s degree or a proven track record of equivalent experience within a commercial environment.

• Minimum approximately five years\xe2\x80\x99 experience of system administration for a validated application within a regulated environment, preferably within the pharmaceutical industry and/or related to regulatory systems.
• Ability to interpret and communicate technical information into business language and vice versa
• Strong influencing, networking and team working skills
• Expert in the drug development process, in particular, regulatory documentation, submission, publishing and approval processes.
• Experience of working in geographically diverse global teams and dealing with cultural differences.
• Expert knowledge of Regulatory systems functionality, policies, procedures and processes.
• Knowledge of the full learning and development lifecycle.
• Use of rapid e-learning tools (e.g. Articulate/Storyline); collaboration tools (e.g. SharePoint, MS Teams); video and graphic production tools (e.g. Camtasia, Kaltura); SCORM/AICC standards
• Key capability requirements:

• Building relationships across, cultures, functions and disciplines to deliver a quality service
• Excellent interpersonal skills
• Delivery and customer focused
• Good organisational skills
• Leadership skills commensurate with Global Career Level

Key Relationships to reach solutions

Internal (to AZ or team)

External (to AZ) * ERV Product Owners

• GRO Strategy / Portfolio / Project Managers
• Business user representatives and users across the enterprise (R&D, QA/QC, Operations, Commercial, Marketing companies)
• Saba System partners (HR)
• IS partners (e.g. R&D IT)

• Peers in other pharma companies and other industries
• IS/IT service organisations
• External service providers (e.g. Veeva, Infosys, TCS)

Great People want to Work with us! Find out why:

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted 14-Jul-2023

Closing Date 13-Sept-2023

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.

AstraZeneca