Senior Specialist, CSO Labelling

Working with Us
Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes 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. Read more: our dynamic Clinical Supply Operations team as a Senior Specialist CSO Labelling and play a pivotal role in supporting global clinical trials.

In this fast-paced environment youll manage multiple labelling projects from concept to completion ensuring regulatory compliance and high-quality standards.

Youll 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!

Key Responsibilities

• 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 is 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.

Required Qualifications Knowledge and Experience

• 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)

Key Competencies

• 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 organizational 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 doesnt 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.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS 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. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

Bristol Myers Squibb is Disability Confident Employer

A UK Government scheme

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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