Label Specialist leads Label development projects/programmes. The individual has a working knowledge of project management methodologies, tools and templates and contributes to the development and maintenance of work products or change programmes. They ensure that business requirements are effectively captured and are responsible for effective tracking and reporting of project management information, as well as highlighting and supporting the resolution of areas of risk in project delivery.
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.
Label development is business-critical and linked to the overall delivery and approval of clinical trials. Frequently, label development activities are on the business-critical path for study set-up and start.
There are key areas of Label Specialist accountability/responsibility:
- SME as a part of the Global Clinical Supply Chain organization, supporting label changes during study maintenance
- Input into study setup/design strategy discussions to ensure the proper clinical labelling strategy is implemented
- Label creation
- Identifying cost saving, assessing timelines and implementing current label development process in optimal way
- Continuous improvement of label development processes (SOPs, WI, GUI, training materials associated with label development)
- Involvement in system upgrades (initiating and driving improvements, review system options)
- Represent AZ as a part of broader Clinical Trial Sponsor’s community to collaborate in the field of new technologies implementation to the labelling process in general (includes external networks)
- Delivery of trainings
- Leads and contribute to the team meetings
- Ensuring effective stakeholders collaboration
- Escalation of risks/issues relating to the systems and activities through appropriate channels
- Development/input to key documents related label creation
- Contribution to audits/inspections
The Label Specialist will require a deep and technical understanding of clinical trials, business processes, and the label technologies associated with clinical supply. Further key capabilities required for this role include:
Change enablement
Flexibility/adaptability
Works Collaboratively.
This role will impact the speed, quality, cost, and risk profile of development projects, affecting the availability of study drugs to patients.
Skills and Capabilities
- Strong computing skills
- Excellent English skills - verbal and written
- Strong communication skills
- Stakeholder management
- Time and task management
- Prioritisation
- Proven analytical and strategic thinking
- High attention to detail
- Excellent data management (entering, interpreting, analysing)
- Ability to learn new information effectively
- Flexibility to react to different customer needs
- GXP (i.e. GMP, GCP, GDP)