Senior Specialist, CSO Packaging and Labelling
Listed on 2026-10-16
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Business
Regulatory Compliance Specialist
At Bristol Myers Squibb, our employees often ask, "Who are you working for?"- a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it. As a Senior Specialist, CSO Packaging and Labelling, you’ll support the production of clinical trial labels and finished clinical supplies, contributing to projects using both internal BMS resources and external supplier partners. You’ll report into the CSO Project Management Lead (Moreton), and you’ll have the chance to learn the fundamentals of clinical supply packaging and labelling while contributing to a fast-moving team.
Requirements
- Support the delivery of clinical supplies by assisting with assigned clinical projects - liaising with Trial Supply Managers (TSMs) on packaging and labelling design, production scheduling, SAP demand entry, and SAP material creation.
- Support multiple projects at once - helping track deliverables (product, code, and label text) against production schedules and flagging issues as they arise.
- Assist in generating internal packaging, labelling, and label print production orders in line with clinical trial design and regulatory requirements, including supporting the creation of BOMs and process orders within SAP.
- Collaborate with CSO, Analytical, and Quality colleagues to support on-time testing and release of assigned projects.
- Support supplier coordination activities, helping track compliance with Master Service, Technical, and Quality Agreements.
- Help prepare project specifications and supporting purchasing documentation, including purchase justification memos and purchase orders, following company policy.
- Assist with reviewing production order schedules and contribute data used for Master Production Plan (MPP) compliance tracking.
- Support the review of vendor- and in-house-generated production orders and related documentation.
- Help compile supporting documentation and batch records that underpin the release of finished clinical supplies, liaising with Quality Assurance as directed.
- Contribute ideas for improving business processes and take part in continuous improvement initiatives as part of the wider team.
- Participate in assigned training, including cGMP training, to build your knowledge and capability over time.
- Experience with in pharmaceutical clinical supply packaging and labelling, with a proven ability to manage complex activities, coordinate cross-functional stakeholders, and ensure delivery within a regulated environment.
- Proven ability to coordinate multiple priorities and stakeholders in a fast-paced environment.
- Strong organisational skills, attention to detail, and a commitment to quality.
- Excellent verbal and written communication skills, with the confidence to work across functions.
- Proactive, solutions-focused, and able to identify and escalation issues effectively.
- Understanding of regulatory and cGMP principles, or experience working within a regulated environment.
- Proficiency in Microsoft Office applications, with the ability to quickly learn new systems and tools.
- Strong collaboration and stakeholder management skills, with a track record of delivering through cross-functional teams.
- Continuous improvement mindset, with a focus on driving efficiency and enhancing ways of working.
We hire for skills and capabilities, not just credentials – if this role excites you, but…
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