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Label Specialist

4 months ago

Gaithersburg, United States AstraZeneca Full time

The Global Clinical Supply Chain function is accountable for the supply of medicines to AstraZeneca’s clinical trials. I order to deliver medicine to patients in clinical trials the patient kit need to have a 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 specialist will support wider Supply Chain organization via development of translated and regulatory compliant study labels using SmartSupplies 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 in SmartSupplies LRA and support of overall label development process improvements. The Specialist must work according to label regulations (i.e. Annex 6) and Good Manufacturing Practice (GMP) standards.

The Label Specialist will support Clinical Study Supply Leads (CSSLs) in label development and change management. This will include:

- Cooperate with CSSLs to convert supply chain study design in to label requirements
- Act on behalf of CSSL during translation activities with external vendor
- Author/review/approve Study Master label document/Label templates and label approval forms

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

- Establishing best practice and ensure issues and learnings are shared both locally and globally
- Support senior roles within the team in development and improvement of the LRA processes, SOPs, guides, instructions and training materials associated with label development
- Perform updates to LRA database (country requirements and translations)
- Deliver Label guidance to CSSLs

**Essential**

The Label Specialist will require 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; 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 significant the financial and reputational impact dimensions of AstraZeneca.

**Education, qualifications, skills, experience and capabilities**:

- University degree
- Strong computing skills
- Excellent English skills - verbally and written
- Proven analytical and strategic thinking
- Demonstration of problem solving skills
- Demonstration of high attention to detail
- Ability to learn new information effectively
- Flexibility to react to different customer needs
- Multi-language skills are a merit

**Label Specialist** role will require:

- Deep and technical understanding of both: business processes and label technologies associated with clinical study supply.
- Change enablement.
- Flexibility/adaptability.
- Strategic leadership.
- Commitment to customers and integrity.
- Working collaboratively.