International Labeling Specialist

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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: careers.bms.com/working-with-us

Position Summary

The International Labeling Specialist will be responsible for providing oversight and project management related to the planning and execution of both submission labeling documents and final approved artwork within in the Labeling department.

The International Labeling Specialist will support the preparation and delivery of accurate, consistent, timely, and compliant labeling documents for submissions to health authorities, and ensure timely and accurate implementation of product labeling for assigned countries.

The International Labeling Specialist will provide key information to assist with the determination in an appropriate and optimal strategy for original and revised labeling text, to drive prompt Health Authority approvals and implementation into the market. The International Labeling specialist will work cross-functionally and globally as required to support the country, region and/or products assigned

Position Responsibilities

• Works under the guidance of the International Labeling Operations Lead or with Senior Specialists.

• Manages external requests for country specific labeling information (e.g. medical content, pharmaceutical properties) from various source or reference documents.

• Notifies appropriate groups or changes or recent source/reference labeling approvals.

• Prepares country-specific labeling in support of safe and appropriate use of BMS products for in-scope countries; maintains country specific translation master-copy to meet labeling responsibilities.

• Prepares, tracks, maintains and reviews required labeling documents (e.g. physician’s label, patient insert, carton, label, blister, tenders) using Text Verification Tools, PRISM / CARA workflow and additional software or process tools to maintain change history for all labeling documents.

• Ensures all labeling supporting documentation and final approved labeling documents (HA approved content and final artwork) match, are status updated, and tracked in the electronic data management system or systems.

• Initiates and approves final printed artwork on behalf of the country when needed for artwork changes and assists with timely implementation of the updated artwork in the market.

• Notifies the artwork studio team, manufacturing, global planning and supply representatives as needed of upcoming changes to labeling. Provide guidance as to when the changes need to be implemented based on information supplied by each market affected.

• Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that result in a product recall due to labeling.

• Maintains an understanding of regulatory labeling requirements of assigned region or countries.

Degree / Experience Requirements

• Bachelor's degree required; Master's preferred with at least 3 years of experience in a regulated environment, including 1-2 years of labeling experience. Labeling experience in the pharmaceutical and/or Bristol Myers Squibb experience is highly desired.

• Military experience will be considered towards experience.

• Proficiency in standard office technology, including Microsoft Suite (Outlook, PowerPoint, Excel) Additional applications such as Adobe and SAP are preferred. Willing to learn additional applications as needed

• Experience working on multi-disciplinary teams and projects

• Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control) is preferred

Other qualifications:

• Basic knowledge of labeling regulations and HA approval structure outside of assigned region or countries, including but not limited to USA and EU

Key Competency Requirements

• Good organizational skills and a meticulous eye for details

• Good understanding of pharmaceutical or medical terminology

• The ability to work as part of a team that supports global functions with a high level of professionalism.

• Knowledge / understanding of another language in a region supported (e.g. Spanish, Arabic, Chinese)

Travel: Occasional travel per to other company sites may be required.

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.

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.