Senior Specialist, CSO Labelling

Working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high‑achieving teams. Bristol Myers Squibb recognises the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives.

As a Senior Specialist in CSO Labelling, you will play a pivotal role in supporting global clinical trials. In this fast‑paced environment, you’ll manage multiple labelling projects from concept to completion, ensuring regulatory compliance and high‑quality standards. You’ll collaborate with cross‑functional teams, leverage cutting‑edge verification and labelling software, and contribute to continuous improvement initiatives.

If you have at least four years of pharmaceutical experience, strong project management abilities, and a keen eye for detail, this is your opportunity to make a real impact in clinical research. Bring your expertise in regulatory principles and passion for excellence; apply today and help drive innovation in clinical supply!

• Create label text for assigned projects in the label text generation and approval system.
• Ensure label text incorporates all study‑specific information provided by Clinical Supply Chain group.
• Utilize appropriate source documentation for drug product information and country‑specific labelling requirements.
• Ensure label text meets all other applicable regulatory requirements; route final label text for approval.
• Interact with local country approvers to resolve any issues.
• Review and approve clinical label proofs against source documentation and ensure compliance with all study‑specific information and applicable regulatory requirements; consult with Regulatory and address queries during label review process.
• Utilize electronic verification software to perform character‑to‑character check on label proof.
• Compile supporting documentation for Quality approval and deliver a body of evidence (label packet) that supports the release of finished supplies for clinical use.
• Create label proofs in label printing software; ensure label proofs contain all information as identified in approved label text specification.
• Maintain labelling section in Country Requirements (CONREQS) database.
• Manage multiple projects – develop detailed time and event schedules, manage and track all activities and milestones related to assigned projects.
• Identify and report issues to management in a timely manner.
• Document deviations – conduct and document thorough investigations.
• Identify and implement appropriate CAPAs.
• Author new and review existing procedural documents.
• Serve as a Subject Matter Expert during Quality and Regulatory audits.
• Identify opportunities for improving business processes and participate on project teams that are focused on continuous improvement.
• Participate in assigned training including cGMP training – provide staff training.
• Develop and issue exacting project specifications to suppliers for outsourcing operations.
• Ensure pricing and terms in label vendor quotation are consistent with MSA.
• Review and approve vendor‑generated project‑specific documents (i.e., LINKS report) – review and approve vendor‑generated production orders and related documents (i.e., change orders).
• Review and approve project specifications for internal label print and packaging and labelling outsourced orders.

• Minimum 4 years pharmaceutical experience preferably in clinical.
• Thorough understanding of pharmaceutical or medical terminology.
• Experience working on multi‑disciplinary teams and projects.
• Good knowledge of rigorous pharmaceutical and scientific documentation practices and change control processes (e.g., revision control).

• Ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast‑paced, rapidly changing environment.
• Exceptional project management skills and detail oriented.
• Excellent decision making and organisational skills.
• Ability to effectively communicate ideas and to influence others to achieve results.
• Ability to understand and apply regulatory and cGMP principles.
• Proficiency in standard MS office technology including Microsoft Suite (Outlook, PowerPoint, Excel) and additional applications such as Adobe.
• Willing to learn additional applications.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Bristol Myers Squibb is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer.