The Clinical Supply Specialist role is to provide operations for the primary packaging, study label text design, secondary packaging activities and distribution of human use labelled supplies to support both the clinical study program and non-clinical consumer/sensory studies in support of the global CHRD categories.

In this role you will be working with external cross-functional teams and with internal functional partners in R&D Categories, R&D QA, Sensory and Consumer Understanding, Regulatory and Marketing to agree product supply requirements and timings for human use study trials.

Once strategy is agreed you will then be working with the internal GMP team members to ensure label printing, packaging and distribution is carried out on target for study start and supporting their activities as required.

This role will be will give opportunities to build experience across the CHRD categories (Oral Care, Pain, Respiratory and Wellness) as well as responsibilities to manage study supply delivery across a global network of sites and through external vendors when needed.

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

• Work across departmental boundaries as Clinical Supplies representative to build efficient and collaborative ways of working with partners in R&D Categories, Clinical Development, Quality, Global Development Operations, Regulatory Affairs and Marketing
• Accountable, through Clinical Supplies team that clinical trials materials are sourced, labelled, packed and shipped following cGMP and compliant with ICH/GCP and FDA regulations, CH SOPs and international shipment regulations to meet category clinical plans
• Responsible for contributing into Clinical Protocols, creating Packaging and Labelling documentation for secondary packing activities and ensuring that the Clinical eTMF documentation is all uploaded and ready
• Support label design and approval, packaging and distribution planning for Non-Clinical (Sensory, Home Use Tests, Trade Assessment) studies
• Support internal primary packaging operations when required as part of lean and flexible team
• Build and maintain partnerships with preferred 3rd party providers to ensure good working relationships to enable efficient outsourcing of clinical supply activities both domestically and internationally
• Support audits through GSK internal audit teams and external regulatory bodies, closing out audit actions as assigned to ensure departmental compliance
• Maintain compliance to internal procedures, update SOP and WIs as per periodic review or driving changes to process, complete Management Monitoring Audits as per assigned schedule and champion compliance across team
• Support the Primary packaging operations by delivering products in their primary package, bottles, blisters, sachets, pouches, etc. and operation of primary packaging equipment setup, operation and cleaning activities

Why you?

Basic Qualifications:

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

• High School Diploma
• Experience working within a clinical trials or human-use study related field

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Bachelor's Degree
• Ability to solve complex problems
• Experience in leading others
• Experience analyzing data
• Excellent communication and presentation skills
• Experience in project management

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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