Senior Label Specialist

2 weeks ago

Macclesfield, United Kingdom AstraZeneca 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**
- 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);
- 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

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