International Labeling Specialist

Bristol Myers Squibb

Tampa, FL 33603

Posted 3 weeks ago

Job Description

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.


**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.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.


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.


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


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.


Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.


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


**Company:** Bristol Myers Squibb


**Req Number:** R1557457


**Updated:** 2022-09-24 02:25:54.341 UTC


**Location:** Tampa,Florida

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.



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