International Regulatory Labeling Specialist

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

Responsibilities:

The International Labeling specialist will work cross-functional and globally as required to support the country, region and/or products assigned.

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 mastercopy 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 and 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 results in a product recall due to labeling.

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

Required:

Bachelor’s degree - or Master’s Degree, preferred in sciences with 2 years of direct labeling experience in a regulated environment, or 3 years with a combination of labeling experience and pharmaceutical experience.*

Must possess an excellent command of language (English) and professional knowledge of medical terms,

Good communication and organizational skills and a meticulous eye for details

Good understanding of pharmaceutical or medical terminology

Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar; 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)

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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com