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Abbott

Makes heart devices, glucose sensors and lab tests

Label Specialist

Regulatory & Quality (Life Sciences)Posted on Nov 11
Full-timeColumbus, OH, USA$61.3k - $122.7kIn-person

About the Job

Requirements

  • A BA or equivalent, plus 4 years of relevant experience.
  • Ability to recognize errors in spelling, punctuation, and grammar.
  • Ability to manage multiple tasks and prioritize to meet deadlines.

Responsibilities

  • Prepare and collect label development information required to initiate label start-up activities.
  • Complete label development activities required to promote label packets from review to approval.
  • Select the appropriate label packet workflow and assess applicable reviewers and approvers.
  • Ensure all appropriate documents are included in the label packet in the designated quality (Change Control) system.
  • Ensure the accuracy and completeness of labels and supporting documentation.
  • Serve as the primary contact for labels requiring third-party translation, request translation services as applicable, and retain translation files and document records.
  • Work with and notify Affiliate-level Regulatory contacts when labels are ready for registration submission.
  • Work with Plant Label contacts to coordinate implementation of final labels for product manufacturing.
  • Collaborate with Plant Label contacts to ensure barcode type and commodity numbers meet country requirements.
  • Manage timelines and escalations, and collaborate with the Project Management group to meet committed product launches.
  • Ensure labeling packets comply with medical, regulatory, marketing, and country-specific requirements.

Desired Qualifications

  • Understanding of label initiation, development, and approval coordination processes.
  • Proficiency with Microsoft applications, including Excel, Word, and Outlook.
  • Proficiency with Adobe Acrobat.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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