At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients 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.

Pharmaceutical Technology and Development (PT&D) is the bridge which turns forward-thinking science into actual medicines that help millions of people. We work across the entire value chain, designing 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. In order to deliver medicine to patients in clinical trials the patient kits need to have translated and regulatory compliant label. The label development is business critical and linked to overall delivery and approval of clinical trials. Frequently the label development activities are on the business-critical path for study set-up and start.

Accountabilities / Responsibilities

The Label Lead will be a key role within AstraZeneca and will be the business process owner for Global Clinical Supply Chain clinical trial label development. The Label Lead will work according to label regulations (i.e. Annex 13) and Good Manufacturing Practice (GMP) standards. The Lead will be responsible for ensuring that AstraZeneca labelling activities are progressed and improved to ensure quality and right level of information is available on labels. The Label Lead will act as the main expert and be responsible to maintain AstraZeneca labelling strategies and ensure high label quality is maintained. 

• Develop and maintain an overall labelling strategy within AstraZeneca for clinical trial labels (valid for all labels regardless if designed/printed internally at DPD or externally)
• Awareness about new labelling initiatives and responsible for how these could be implemented within AstraZeneca (E-labels, Just-in Time etc) e.g. be the link to Our Future Reimagined
• Responsible for evaluation/improvement of the current label development process (LRA) and coordination of required LRA application and LRA process changes
• Lead cross-functional global label network (members Label Specialists, DPD, QA, Reg, Sourcing and Clinical Study Supply Lead (CSSL))
• Coordinate operational LRA delivery through resource planning and provide advisory support to label specialists
• Responsible for establishment of good collaboration between AstraZeneca label team and MedI LCS System Management team and maintaining this good relationship
• Accountable for IQVIA collaboration/KPIs/BRM
• Accountability Label deviation track and trend
• Accountability Label training
• Accountability for Label change control
• Responsible for budget for label translation and regulatory label requirements

In addition, the role holder will work as a part of a leadership team and is responsible for leading, developing, and giving guidance to the team of label specialists.

The role holder will:

• Ensure development and performance management of the team and individuals;
  • Agreeing and maintaining team and individual objectives aligned with the wider organisation;
  • Regular coaching on individual and team performance
  • Staff development in technical skills and leadership capabilities
  • Annual and spontaneous recognition and reward of individuals
  • Managing disciplinary and grievance issues within their team

• Provide courageous leadership to direct reports, acting as a role model and giving clear directions to the team  during periods of change and ambiguity.
• Ensure SHE/GMP standards are upheld; accountable for establishing improvement and action plans in these areas as required; ensure AZ Policies and Standards are understood and followed

Essential

The Supply Chain Label Lead will require a deep and technical understanding of both the business processes and the label technologies associated with clinical supply.  Further key capabilities required for this role include: Change enablement; Flexibility/adaptability; Strategic leadership; Commitment to customers and integrity, and Works 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.

Skills and Capabilities

• 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 effectively
• Flexibility to react to different customer needs
• Multilanguage skills is a merit

Are you ready to make a difference? Send in your application, and explore this opportunity, where ‘putting the patient first’ is key to everything we do!

Date Posted

Closing Date

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.