Senior Label Specialist
Location: Cheshire East
Job Type: Full time
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
Senior Label Specialist will be a part of Global Clinical Supply Chain organization by acting as subject matter expert in the following areas:
- involvement in study setup/design strategy discussions to ensure the proper clinical labelling strategy is implemented (identifying cost saving opporunities, assessing timelines and implementing current label development process in optimal way);
- delivery of subject matter trainings and guidances for CSSLs, CSCCs, Fisher CSOS;
- continiuous improvement of label development processes (SOPs, procedures and training materials associated with label development);
- involvement in Label Expert Group with active participation to the meetings, providing input the agenda items, contribution to actions identfied;
- responsibility for scoping and driving label-related change controls;
- support CSSLs by spreading awareness on label development processes to other departments within the company (Clinical Teams, Regulatory)
Senior Specialist will be responsible for advanced label-related tasks, which include the following:
- coordination of product booklet labels creation
- acting as SME and being advisory body for CSSLs when any changes in study design happens during study maintenance
The Senior Label Specialist will support current labelling process development via following activities:
- involvement in system upgrades and support SmartSupplies Team in performing UATs
- represent AZ as being 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 joining symposia and external networks)
- support Label Lead with looking for AZ labelling strategy opportunities and responsible for assesing how these could be implemented within AstraZeneca (E-labels, Just-in Time etc.)
The Senior Specialist will act as role model and support to Label Specialists, which involves:
- Delivery of trainings for Label Specialists
- Being a mentor for Label Specialist by various activities, e.g.: maintaining 1:1 informal relationship, to hold ‘open doors session’ as well as regular touch-base meetings, time slots pre-booked according to mentees needs
- to be a ‘sounding board’ for work-related honest/open advice.
- sharing the ‘bigger picture’ on e.g. Global Clinical Supply chain or general clinical trial design etc.
Education, Qualifications, Skills and Experience :
The Senior Label Specialist 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
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.