Manager, Business Services

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.  

Regulatory Technology & Operational Excellence (RTE) is accountable for ownership of ERV, ensuring it is effectively developed, maintained, governed and supported across the enterprise to meet scientific, business and compliance needs.

The ERV Business Services Manager plays a key role in controlling access, maintaining security, and facilitating the efficient and effective use of ERV , as well as other systems supported by RTE. In addition, this role applies specialized knowledge relating to learning, support and enablement, to ensure that customers gain full value from available information assets . The role will develop effective relationships in support of these activities, both within Regulatory and across the wider enterprise, building competency/capability within the business areas, through analysis, identification and delivery of appropriate learning and support interventions.

Key Responsibilities:

• Delivery of high quality expertise and services across relevant areas of RIM system activity, ensuring that prioritized requirements and strategic goals of customers in AZ Regulatory and the wider enterprise are recognised and supported.
• Responsible for maintaining and regularly monitoring systems access and security in accordance with agreed procedures and conventions.
• Providing relevant process and system-related guidance and support for deliverables, where required.
• Responsible for the effective and efficient management of systems communication methods, e.g. SharePoint, OneNote, Workplace.
• Provides expert input to the ongoing development and implementation of the Reg Tech portfolio, ensuring quality, efficient and timely delivery of assigned activities.
• Delivery of robust activity planning in support of prioritized deliverables and productivity targets.
• Provides specific expertise in relevant areas of systems administration, learning development and systems enablement to challenge and support the RTE team in proactive risk identification, solution building and issue resolution.

• Provides expertise to project teams to ensure that solutions are supported by robust learning and support interventions that will build competency/capability in the effective use of the solution and demonstrate compliance with relevant legal and/or regulatory requirements, e.g. GxP.
• Collaborates closely with other experts across Reg Tech or more widely (e.g. OSSE, IT, external partners) who are involved in the design, development and delivery of IT-related solutions, or related business deliverables such as policies, procedures, processes and guidance.
• Maintain awareness of opportunities for self and the team to co-develop and/or utilize wider information and systems resources to address common cross-functional business needs.

• Manages relationships effectively with partner organizations and external experts involved in the delivery of Reg Tech work.

• Fosters a culture within Reg Tech that promotes compliance with all relevant AZ policies and procedures.
• Adopts flexible and adaptable approach towards new opportunities, tasks and ways of working.

Essential Education, Experience & Skills:

• Bachelor’s degree or a proven track record of equivalent experience within a commercial environment.
• Minimum approximately three years experience of system administration for a validated application within a regulated environment, preferably within the pharmaceutical industry.
• Minimum approximately three years experience of working with an enterprise wide Document Management System and/or other tools supported by RTE (e.g. publishing / tracking).
• Minimum approximately three years experience of delivering system support and/or training to end users.
• Clear evidence of organisational skills and experience of change control management and administration.
• Evidence of development and implementation of effective learning and/or support interventions for validated applications within a regulated environment, preferably within the pharmaceutical industry.
• Knowledge of 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.

Desired Experience & Skills:

• Expert knowledge of RTE 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); 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

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.