Senior US Labeling Specialist

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.

The Senior US Labeling Specialist will be responsible for providing oversight and project management related to the planning and execution of US Labeling operational activities. You will be responsible for ensuring accuracy, consistency, and alignment of Bristol-Myers Squibb labeling with the FDA Regulations and BMS Policy. This role offers broad scope, diverse opportunities, and global visibility.

The Senior US Labeling Specialist will manage critical stakeholder labeling communications and activities, ensuring timely and accurate implementation of product labeling for US launches and ongoing compliance requirements, recognizing that the US is a priority market for BMS.

The Senior US Labeling Specialist will advise on US labeling regulations and best practice as the Subject Matter Expert to Global / US Regulatory.

The Senior US Labeling Specialist will ensure high quality and accuracy of all labeling for dissemination to wide and critical audiences by applying complex technical document/content conversion skills.

Position Responsibilities:

• Works independently and serves as a back-up for the Senior Manager and/or Manager, US Labeling Operations
• Manages external requests for data with professionalism and adherence to policy and regulations
• Prepares and distributes US labeling submission documents that meet FDA and BMS internal standards (including annual reports, xml, and eCTD documentation)
• Manages the end-to-end labeling process to minimize the risk and associated costs to BMS and patients of a significant error occurring in final labeling preparations that results in a product delay or recall due to labeling
• Approves and maintains artwork for US packaging components including decision when artwork should be printed “at risk”
• Subject Matter Expert advisor to Global / US Regulatory, Submission and project development teams on FDA Labeling requirements, labeling change control, and potential labeling issues to manage regulatory requirements, timeline risks, and impact on patients and other stakeholders
• Communicates with internal and external stakeholders to improve processes and manage unmet needs
• Collaborates with contributing functional areas and external sources to verify accuracy of submission labeling components in the required formats. Advises Global Product Development & Supply of upcoming changes to labeling and provides guidance on when changes need to be implemented in the market; this responsibility encompasses safety and quality labeling compliance
• Maintains up-to-date knowledge of extensive and complex US regulatory labeling requirements, assessing and communicating impact on BMS business and products (working with BMS policy group as appropriate).
• Trains / mentors new staff and develops job aids or update user guides as needed
• Proactively identifies risks and issues and develops solutions to challenging areas related to assigned projects in the interest of keeping projects streamlined and moving forward

Required Experience:

• Bachelor’s or Master’s degree preferred in science with 3 years of direct labeling experience in a regulated environment with 1 year in the pharmaceutical industry*
• Must possess an excellent command of language (English)
• Excellent communication and organizational skills and a meticulous eye for details
• Solid knowledge of medical and scientific terminology, and biopharma manufacturing complexities
• Solid understanding of FDA Regulatory and Labeling regulations and standards
• 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
• Ability to align personal objectives with the Packaging and Labeling and business strategies to make the best possible judgments
• Professional knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g., revision control)

Ideal Candidates Would Also Have:

• Experience of the complexities of US Health Agency requirements
• The ability to work as part of a team that supports global functions with a high level of professionalism in the pharmaceutical and scientific documentation discipline

Other qualifications:

• US military experience will be considered towards industry experience requirements

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.

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