Director, RIM Systems

AstraZeneca UK

Location: Cambridgeshire, Cheshire East

Job Type: Full time

Posted


Do you have expertise in, and passion for Regulatory Information Management systems, delivering business benefits to users and managing change to ensure continual improvement? Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

About AstraZeneca

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Global Regulatory Operations

We are now looking for a Regulatory Information Management Systems (RIMS) Director to join us in Global Regulatory Operations (GRO) within Regulatory Affairs as a Senior Change Release Manager. This is a growing area within a globally connected business, and a place to share learnings and best practices with our leading Regulatory specialists and IT colleagues. Working across our locations, therapy areas and external community means we’re comfortable stepping up, willing to take ownership of our work, in an effort to find solutions for the business and our personal career development.

The jobholder will be a member of the RIMS change release management team, a business-side group that works in close collaboration with other business and IT members of the Regulatory Platform team. The primary accountability of the team is to establish and manage a long term roadmap for changes to the ERV platform, manage platform releases and ensure the continuous improvement of the platform from the business perspective

What you’ll do

As a member of the RIMS change release management team you will be responsible for the planning, coordination, monitoring and delivery of agreed system and configuration releases within the RIM / ERV (Enterprise Regulatory Vault) platform. ERV is AstraZeneca's business-wide system for Regulatory Information Management (RIM).

As a data-centric cloud / SaaS platform, ERV 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.

With this in mind we think you have a robust understanding of cloud based regulated platforms, experience in managing change to validated GxP applications, knowledge of the regulatory function within the biopharma industry and experience in agile delivery of business applications to a globally distributed user base.

Specific responsibilities can include:

  • Establishing and managing a roadmap for the ERV-RIM platform, working collaboratively with the ERV platform and governance teams

  • Managing complex business change projects within the ERV change management structure

  • Creating, refining, prioritizing and agreeing business requirements

  • Ensuring proposed solutions address requirements and deliver business benefits

  • Partnering with Training, Change and Communications lead to ensure training and user support materials are assessed and updated in support of releases, and to manage business-focused project communications.

  • Ensuring validation testing is planned, prepared and executed in a timely fashion and to appropriate quality standards

  • Coordinating business resources for validation testing, e.g. URS, Acceptance Testing, Operational Qualification Testing

  • Anticipating, documenting and addressing (or mitigating) program issues and risks in a timely, efficient and effective manner, and where appropriate, are escalated to Product Owners and Strategic Product Director

  • Effectively managing project scope and escalating significant issues in this regard to the Product Owners and Strategic Product Director

  • Coordinating activities, working closely with the IT release manager to ensure successful delivery.

  • Ensuring that all documentation, as defined in the applicable methodology, is produced, reviewed, approved and retained.

  • Maintaining appropriate project plans in coordination with the IT Release Manager.

Education, Qualifications, Skills and Experience

Essential for the role:

  • Bachelor’s degree or equivalent experience within the pharmaceutical or IT industries.

  • Experience of delivering projects across the global enterprise and operating in a complex environment with multiple stakeholders, particularly with a significant IT component.

  • Experience in agile delivery of business applications to a globally distributed user base

  • Good understanding of current system development lifecycle methodologies.

  • Awareness of current developments in the pharmaceutical industry and global regulatory environment in the electronic submission arena (evolving regulatory information standards, processes and technology).

  • Knowledge of regulatory documentation, submissions, publishing and approval processes.

Desirable for the role:

  • Professional qualification in project/programme management or a proven record of successful project management/delivery, particularly at the business/IT interface.

  • Experience of delivering enhancement projects for a GxP, ER/ES or other ‘regulated’ system.

  • Key capability requirements:

    • Clarity of direction and ability to manage multiple stakeholders in a globally diverse and cross-cultural environment

    • Understanding and management of risk

    • Building relationships across, cultures, functions and disciplines to achieve delivery

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save plans, A performance recognition scheme and a competitive, generous remuneration package.

Where can I find out more?

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Date Posted

22-Nov-2022

Closing Date

29-Nov-2022

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.

You’ve got this!