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.

ABOUT THE ROLE

Global Clinical Supply Chain department is accountable for the supply of medicines to AstraZeneca’s clinical trials around the world. In order to deliver medicines to patients in clinical trials, patient kit needs to have a translated and regulatory compliant label. Clinical label development is business critical step and linked to overall delivery and approval of clinical trials. Frequently label development activities are on the business-critical path for study set-up and maintenance.

Main Duties and Responsibilities:

Label Specialist will support wider Supply Chain organization by driving development of translated and regulatory compliant clinical labels using SmartSupplies system - LRA (Label Routing and Approval) module and LRA process. This includes activities related to new regulatory requirements for labels and identification of new base phrases and translations in SmartSupplies LRA as well as implementing label development process improvements. Label Specialist must work according to clinical label regulations (i.e. EudraLex Annex 13) and Good Manufacturing Practice (GMP) standards.

Label Specialist will act as expert and support/replace Clinical Study Supply Leads (CSSLs) in label development process and change management.

This will include:

• Supporting CSSLs to convert supply chain study design in to label requirements.

• Replacing CSSLs during translation and label design activities with external vendors.

• Authoring/reviewing/approving Study Master Label Document, label templates and label approval forms.

In addition, as a part of a wider Label Specialist Network, Label Specialist will contribute to:

• Establishing best practice and ensuring issues and learnings are shared both locally and globally.

• Development and continuous improvement of LRA process, SOPs, procedures, and training materials associated with label development.

• Keeping LRA database updated (country requirements and translations).

• Delivery of Label training and guidance to CSSLs team.

• Supporting wider Supply Chain organization with general label expertise.

Education, Qualifications, Skills and Experience:

Label Specialist role will require:

• Deep and technical understanding of both: business processes and label technologies associated with clinical supply.

• Change enablement.

• Flexibility/adaptability.

• Strategic leadership.

• Commitment to customers and integrity.

• Working collaboratively.

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

Other Skills and Capabilities:

• University degree.

• Strong computing skills.

• Excellent English skills - verbally and written.

• Proven analytical and strategic thinking.

• Demonstration of high attention to detail.

• Ability to learn new information quickly and effectively.

• Flexibility to react to different customer needs.

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity, no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next?

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

Date Posted

26-sie-2021

Closing Date

18-wrz-2021

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.