Enterprise Regulatory Vault ERV Business Services Manager

Enterprise Regulatory Vault (ERV) is AstraZenecas businesswide system for Regulatory Information Management (RIM). As a datacentric 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 Regulatory Information Management system activity ensuring that prioritized requirements and strategic goals of customers in AZ Regulatory and the wider enterprise are recognized and supported.
• Responsible for maintaining and regularly monitoring systems access and security in accordance with agreed procedures and conventions.
• Providing relevant process and systemrelated guidance and support for deliverables where required. eg Veeva Vault Publishing and Document Management related queries.
• 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.
• 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 health authority requirements.
• 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 ITrelated solutions or related business deliverables such as policies procedures processes and guidance.
• Maintain awareness of opportunities for self and the team to codevelop and/or utilize wider information and systems resources to address common crossfunctional business needs.
• Fosters a culture within Regulatory 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:

• Bachelors 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 enterprisewide Document Management System/Publishing/Tracking tools supported by RTE (Regulatory Tech Operations Excellence
• Minimum approximately three years experience of delivering system support and/or training to end users.
• Clear evidence of organizational 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 elearning tools (e.g. Articulate/Storyline); collaboration tools (e.g. SharePoint); SCORM/AICC standards
• Experience with Document Management and Publishing Tools eg (Veeva Vault CARA Docubridge First Doc eCTD Xpress Lorenz)
• Key capability requirements:
• Building relationships across cultures functions and disciplines to deliver a quality service
• Excellent interpersonal skills
• Delivery and customer focused
• Good organizational skills
• Leadership skills commensurate with Global Career Level

Date Posted