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Pharmaceutical Labeling Operations Coordinator

Company: Bristol-Myers Squibb Company
Location: Tampa
Posted on: February 14, 2019

Job Description:

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.Responsible for proofreading labeling-related documents, preparation and review of supporting labeling documents to support GRCSC, including but not limited to the CCDS, US & Reference Labeling (Word document/SPL submissions, artwork). Responsibilities also include preparation of Composition copies, Structured Product Labeling (SPL). This position is essential to avoid costly rework of incorrect artwork, product recalls and also re-submission of corrected materials to the FDA and other Health Authorities, which entails potential compliance risks. This position is an integral part of the program to maintain overall quality standards, and track for performance metrics.

  • Proofread prescription drug labeling, packaging and submission documents for US & International markets -primarily in English. Spanish, or other international market proofreading capabilities will be an advantage
  • Review documents for accuracy, clarity, and consistency of content and format; correct spelling, grammar, and punctuation
  • Highlight (for additional review) other non-grammatical inconsistencies observed such as with artwork or layout when proofreading materials
  • Coordinate and collaborate with internal and external stakeholders to ensure delivery timelines are met
  • Create supporting US labeling documents: Composition copy, SPL, core template; coordinate with other Coordinators and Labeling Specialists to meet delivery standards and deadlines
  • Verify language sources from SmPC and USPI for international markets; mark up inconsistencies and escalate to Labeling Specialist for review and remediation
  • Maintain proof-reading tracker; enter real-time data (US and International) on status of proof-reading activities
  • Ensure recent major USPI changes are applied, verifying hyperlinks in annotated documents and ensure accuracy of cross references in labeling
  • Participate and work in team environment, working and communicating on multiple projects and tasks effectively and in a timely manner
  • Train and mentor Pharmaceutical Labeling ProofreadersRequired:
    • Bachelor's degree (Science or English) preferred
    • A minimum of 1 year of labeling proofreading experience in a regulated environment, or at least 3 years other specialized proofreading or pharmaceutical experience
    • Excellent command of English grammar, spelling and punctuation.
    • Prior experience proofreading, preferably in a regulated environment, including use of a range of tools
    • Demonstrated capabilities in meticulous work practices, attention to detail and working in a team environment
    • Proficiency in standard office technology, including the Microsoft Office Suite
    • Good understanding of pharmaceutical or medical terminologyIdeal Candidates Would Also Have:
      • Familiarity with labeling-related regulations and industry practice a plus
      • Experience in proofreading, including prescription drug labeling
      • Prior experience with electronic proofreading tools a plusOther qualifications*:
        • Spanish, or other international market proofreading capabilities a plus
        • US military experience will be considered towards industry experience*Direct BMS experience may be considered instead of Labeling experience/ college degree/ managerial experience

          Keywords: Bristol-Myers Squibb Company, Tampa , Pharmaceutical Labeling Operations Coordinator, Healthcare , Tampa, Florida

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