Bristol-Myers Squibb Company

Senior Global Labeling Operations Specialist

Location
Tampa, FL, US
Posted
Sep 22, 2018
Ref
R1509821
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 Global Labeling Operations Specialist works in close collaboration with the Global Labeling Leads to ensure that the Company Core Data Sheet (CCDS) is meets BMS document formatting and editorial standards for global distribution. He / she plays a key role in ensuring that CCDS and supporting documentation are inspection- and audit-ready. He / she interacts with Regulatory Information Management Services (RIMS) to ensure timely dissemination of the CCDS.
The Senior Global Labeling Operations Specialist is also responsible for maintaining the Global Book of Work (BOW) for Global Labeling, consolidating information from the Verity database and other sources.

Responsibilities:
  • Maintains the Administrative Information (History of Revisions) for CCDSs
  • Ensures that all references and supporting documents are available and in CARA / PRISM or other appropriate electronic systems and repositories
  • Conducts QC, proofing, editorial/grammatical revisions and formatting of the final CCDS-related deliverables in compliance with Company-driven targets, including the CCDS clean copy, mark-up versions, executive summary of CCDS changes and distribution emails.
  • Verifies referencing of CCDS text against cited source documentation, including format and numbering of endnotes/citation numbers, and consistency of reference citation style
  • Maintains CCDS template and editorial style guide, and provides guidance and directions on updates
  • Works closely with RIM-Services to ensure timely dissemination of the CCDS
  • Supports Global Labeling Leads in research of labeling precedents (competitor labels and recent HA decisions)
  • Maintains Global Labeling SharePoint Site and ensures that all relevant information is updated in time
  • Facilitates collecting local requirements for global changes, eg, plant transfers, serialization
  • Maintains BOW for Global Labeling to support resource allocation
  • Effectively engages with the Team and seeks out support when appropriate


Qualifications:

Required:
  • Bachelor's or Master's degree, preferred in, ³3 years of direct labeling experience or regulatory affairs function equivalent, with ³1 year in the pharmaceutical or device industry, in a regulated environment.
  • Excellent command of English language
  • Solid knowledge of medical and scientific terminology, and biopharma manufacturing complexities
  • Ability to develop strong and positive working relationships across diverse teams and within a global environment
  • Excellent communication, time management and organizational skills, including a meticulous eye for details
  • Proficiency in standard office technology, including Microsoft Office Suite, Outlook Mail/Calendar, and willing to learn additional applications as needed
  • Professional knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (eg, revision control)


Ideal Candidates Would Also Have:
  • Project management experience
  • Experience and knowledge of document management
  • Solid understanding of Global Labeling regulations and standards


Other Qualifications:
  • US military experience will be considered towards industry experience requirements