Do you have strong expertise or experience in IRT and passion for delivering patient clinical supplies? Would you like to apply your expertise to impact the lives of patients in a team that creates smart ways to deliver and manage life-changing medicines? Then joining the IRT Specialist team could be just right for you!

At AstraZeneca, we turn ideas into life-changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being ambitious, 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.

Business area

Pharmaceutical Technology and Development (PT&D) is the bridge that turns forward-thinking science into actual medicines that help millions of people. We work across the entire value chain, crafting and delivering active ingredients, formulations, and devices required to support new medicines – from supplies for use in clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

The Global Clinical Supply Chain function is accountable for the supply of medicines to AstraZeneca’s clinical trials. The use of Interactive Response Technology (IRT) allows automated inventory management to maintain the right kits, for the right patients, at the right time, and in the right place. For each study, Clinical Operations and Global Clinical Supply Chain collaborate closely to build specific IRT requirements which are then configured and validated by the IRT vendor.

IRT is a critical and strategic business application that directly impacts the speed, quality, and cost of AZ’s clinical studies. Frequently, configuration/validation activities are on the critical path for study start-up.

What you’ll do

The IRT Lead is accountable for delivering the GCSC inputs to the onboarding and continuous improvement of IRT standards and studies which can include but is not limited to:

• Inputting to and completing Technical Standards documentation both standards and studies
• Completing Risk Assessment both standards and studies
• Author/approve test scripts as required– both standards and studies
• Develop and deliver training material on standards
• Build internal SOP’s to detail and define process
• Represent Global Clinical Supply Chain in governance interactions, both internal and external

The IRT Lead will act as a role model and expert consultant to IRT Specialists and within both GCSC and Clinical Operations, which involve:

• Delivery of training and onboarding support for IRT Specialists & mentoring of new team members – individuals performing this role will be classed as trainers
• Leading development and process activities within the team and across teams, such as knowledge-sharing activities and information sessions
• Consultancy to internal and external groups for both study solutions and process development, as well as assessing programme strategy and proposing solutions to meet programme needs
• Process owner for IRT processes / sub-processes
• Drives and role models excellence in delivery in IRT Set up and organisational change and associated values and behaviours and develops excellence in others through their interactions with them.

The IRT Lead is also accountable for the top tier of projects to develop future solutions and to innovate to meet challenges of the future supply chain, for example, direct-to-patient in IRT projects, Just-In-Time, pooling, or other novel innovations.

This role will affect the speed, quality, cost, and risk profile of development projects and the overall portfolio, and impact the availability of study drugs to patients. As such, it has the potential to significantly impact the financial and reputational dimensions.

Essential for the role

Must have skills:

• Degree or equivalent professional qualification
• In-depth knowledge of the Clinical Supply Chain and drug development process.
• In-depth knowledge of Clinical Development processes relevant to investigational products.
• In-depth knowledge of IRT systems, interactions and integrations
• Proficient IT skills with an ability to understand, adapt and operate in multiple systems.
• Strong influencing, negotiating, and problem-solving skills, including across functional, geographical, and cultural boundaries.
• Awareness of cGXP, especially relating to computerized systems.
• Risk identification and management.
• Excellent written and verbal communication skills.

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 ready to bring new ideas and fresh thinking to the table? Brilliant! We welcome with your application!

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

If you have site, country or departmental social media then feel free to switch any of the above links.

Date Posted

Closing Date