The Global Pack Management (GPM) Team within Clinical Supply Chain Packaging Operations is responsible for the creation and sourcing of secondary packaging components for all products to be packaged internally within GSK’s clinical trial arena, the management and control of all label content regulatory requirements and translations within the SMART LS label creation system for all countries/languages where clinical trials are held and the creation and approval of all label content for clinical trial labels across multiple modalities, liaising within 60 plus countries globally, as well as interfacing with GSK’s Clinical Interface/CTSM team to determine delivery timescales.

The External Label Specialist will liaise with the Clinical Interface/CTSM teams to create the label content and liaise with multiple third party manufacturing/packaging companies to create and approve the final GSK Clinical Trial labels, using GSK Systems such as SMART LS and Prisym. The approved labels will be used for labeling clinical trial supplies packaged at third parties. In addition, the role will have opportunity to cross train in a number of additional areas within GPM.

This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:

• Work within a global team, create master label content according to existing processes and procedures specific to each modality
• Liaise with third party contract manufacturing/ packaging companies to provide label content and receive labels created by the third parties For Use by GSK Employees within R&D MDS and GMP QA
• Perform quality critical checks of label content produced in various languages within the required timelines
• Create label documentation, required for in-country regulatory submissions, in a timely manner
• Perform the translation management role within SMART LS, liaise with third party translation providers
• Identify opportunities for process improvement
• Ensure quality right first time across all elements of the label creation process
• Participate in quality investigation activities (Root Cause Analysis, Product Impact Assessment, Mitigation Action definition), potential to become a business lead investigator
• Own and implement corrective and preventive actions (CAPAs)
• Motivated to self-assign core tasks, prioritizing and completing as part of a wider team with minimal supervision/ input
• Work with external vendors, such as translation service provider and third party clinical trial label approvers
• Participate in department improvement projects, identify process improvements
• Participate in GPM team meetings
• Liaise with other groups within Clinical Supply Chain such as Clinical Interface/CTSM and Quality Assurance

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Understanding of cGMP requirements and regulatory requirements
• Proficient in Microsoft package and Adobe tools
• Ability to work between multiple GMP IT software systems, adapt to changing systems
• Ability to follow written instructions
• The ability to work effectively with others to meet timelines, business goals and objectives.
• Excellent verbal and written skills Ability to work individually as well as part of a team
• Ability to challenge the status quo
• Capacity to work in a cross cultural environment

Why GSK?

Uniting science, technology and talent to get ahead of disease together

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

#LI-GSK

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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