Bristol-Myers Squibb Company

Senior US Labeling Specialist

Location
Tampa, FL, US
Posted
Nov 19, 2018
Ref
R1509829
Required Education
Bachelors Degree
Position Type
Full time
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.

  • 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 translation skills.


They will/must:
  • Works independently and serves as a back-up for the Lead, 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 in order to manage regulatory requirements, timeline risks, and impact on patients and other stakeholders
  • Communicates with internal and external stakeholders to improve on 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.


Desired Experience/

Required:
  • Bachelor's or Master's degree, preferred in science with ³ 3 years of direct labeling experience in a regulated environment with ³1 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 Excellent communication and organizational skills and a meticulous eye for details
  • 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 in order 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


*Direct BMS experience may be considered instead of Labeling experience/ college degree/ managerial experience