Labeling Proofreader Jobs

• Excellent writing, communication and collaboration skills, with the ability to work effectively with cross-functional teams

• Experience with data annotation tools and techniques

• Execute plans to test the safety of our language model.

• Stay up-to-date on the latest techniques and tools to ensure the model remains secure.

• Strong attention to detail and ability to maintain a high level of accuracy

• Familiarity with large language models, such as ChatGPT or Google Bard

Excellent writing, communication and collaboration skills, with the ability to work effectively with cross-functional teams

Experience with data annotation tools and techniques

Experience with large language models, such as ChatGPT or Google Bard

Execute plans to test the safety of our language model.

Stay up-to-date on the latest techniques and tools to ensure the model remains secure.

Generative AI Language Research team

2+ years of labeling experience within medical device/pharma/food industry

Ensures that labeling art film and plate proofs meet all medical legal and regulatory requirements.

***Compensation within this range will be commensurate with level of experience***

Monitors changes in labeling regulations in the US and/or abroad.

Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.

Monitor evaluate and recommend improvements to labeling processes quality systems tools and/or policies.

Implement pre-approved changes to workflows and knowledge repositories.

Excellent writing and communication skills

Linguistic skills including morphology and syntax (correct grammatical, spelling, typographical, or compositional errors)

Excellent organizational skills with attention to detail

Excellent technical and computer skills

As an Data Labeling Specialist, you will be supporting the team by maintaining quality and accuracy of native language content.

Implement pre-approved changes to workflows and knowledge repositories.

Excellent writing and communication skills

Linguistic skills including morphology and syntax (correct grammatical, spelling, typographical, or compositional errors)

Excellent organizational skills with attention to detail

Excellent technical and computer skills

Locations: San Francisco, CA | Seattle, WA

Manage labeling projects from planning to execution, ensuring accuracy and compliance with regulatory requirements.

Knowledge of regulatory requirements for labeling in the Nutrition industry.

Work with manufacturers to ensure compliance with US dietary supplement and food product labeling requirements.

Ability to work in a fast-paced environment and manage multiple projects simultaneously.

Strong communication and collaboration skills.

Collaborate with internal cross-functional teams to ensure labeling timelines align with product launch timelines.

Initiate change requests for new and revised labeling, work with Labeling Coordinators to create, maintain, and implement compliant labeling.

Good understanding of how labeling systems communicate with other business systems

Ability to lead team efforts on labeling projects.

Able to perform work with a high degree of accuracy and minimal supervision.

Commitment to learn and stay abreast of medical devices regulations. Understand the overall business environment, the orthopedic industry, and the marketplace.

* Please note, this position is a hybrid role, that sits partially onsite, in Warsaw, Indiana.

Experience in the ag-chem or other chemical industry helpful to understand the critical nature of labeling accuracy and requirements.

This position does not require creativity design experience. It requires more attention to details and organizational skills.

Attention to detail skills a must!

Ability to learn new technology applications. Adobe Creative Suite (InDesign, Illustrator) knowledge a plus.

Clerical and critical thinking skills.

Creates California Printer’s Proofs for Regulatory Specialists submissions.

Must be capable of interfacing with executive level of management and health care professionals

Providing guidance, as required, on requirements

Demonstrating a broad knowledge of product development process

Knowledge of global medical device labeling regulations and standards (i.e. FDA, ISO 1485, EU MDR, etc.)

Additional qualifications that could help you succeed even further in this role include:

Providing leadership and direction to the Labeling team

Demonstrate accurately and thoroughly in a timely manner to meet production standards

Properly label and sticker product, in order to ensure fulfillment of deliveries

Work in collaboration with all members of the vault to ensure production standards are delivered upon

Ensure that the correct labels are affixed to the correct products

The ability to lift 25/50 pounds regularly

Able to work weekend and off hours

Implement pre-approved changes to workflows and knowledge repositories.

Help support and exchange knowledge with other PDO DLAs.

Strategic & Organized: Ability to manage multiple projects/workflows/ communication channels simultaneously.

Organize logistics for data collection projects as needed.

Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).

Ensures that all regulatory labeling items and information is appropriately tracked, archived, searchable and accessible.

Works directly with Regulatory Project Mangers to prepare labeling items consistent with content project plans.

Site Quality Systems Management: CAPA, Change Control, Deviations, Investigations, Risk Assessment, and Vendor Change Notification with emphasis on labeling/packaging operations

Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)

Experience with labeling/packaging operations preferred

Experience with supervision and training of personnel preferred

Working knowledge of GMP principles with respect to FDA and EMA regulations

Working knowledge and technical understanding of the manufacture and testing of biologics

Excellent project management, and critical thinking skills

Reviews domestic and/or international labeling for compliance to labeling requirements including content, format and regulatory submissions

10+ years of relevant experience

Advanced knowledge of the scientific principles of the drug development process

Advanced, broad knowledge of regulations pertaining to drug product labeling

Excellent oral and written and written communication skills

Good time management and organizational skills

Full knowledge and understanding of policies, procedures, and requirements as it relates to task execution within labeling operations

Good knowledge of labeling requirements across business units

Associate's Degree with 4 years of related experience OR H.S. Diploma with 6 years of related experience required

Good computer skills including usage of MS Office Suite

Good written and verbal communication skills and interpersonal relationship skills

Strong editing/proofreading skills, including broad vocabulary and knowledge of medical/scientific terminology.

Bachelor’s degree plus 2 years experience* in proofing pharmaceutical labeling, packaging components or medical/scientific documents.

4 plus years experience in pharmaceutical proofreading may be considered in lieu of degree.

Ability to apply these skills across multiple languages, especially non-native language is highly desirable.

Excellent interpersonal, organization and communication skills.

Labeling document comparison experience was missing among the applicants.

Excellent computer, organizational, and project management skills.

MA / MS Degree with 6+ years of Supply Chain and/or Project Management and/or Labeling experience

BA / BS Degree with 8+ years of Supply Chain and/or Project Management and/or Labeling experience

Associate Degree with 10+ years of Supply Chain and/or Project Management and/or Labeling experience

High School Diploma / GED with 12+ years of Supply Chain and/or Project Management and/or Labeling experience

Manages complex processes across functions and interacts effectively with the other team members to ensure product labeling meets regulatory requirements.

Bachelor's Degree with 1 year of related experience Required

Previous experience working in a medical/pharmaceutical FDA regulated industry

Excellent written and verbal communication skills and interpersonal relationship skills

Basic knowledge of medical device documentation development activities

Knowledge of ECR and Ignite processes

Good computer skills including usage of MS Office Suite

Implement pre-approved changes to workflows and knowledge repositories.

Generate robust documentation of processes and templated reports to Help support and exchange knowledge with other PDO program areasDLAs.

Strategic & Organized: Ability to manage multiple projects/workflows/ communication channels simultaneously.

Leadership in the face of ambiguity: Experience working independently, stepping up to address a problem even when not given clear instruction.

Perform quality audits to provide labeling metrics and insights, support policy guideline updates, and recommend optimization opportunities across the labeling programs.

Help vendors unblock obstacles by sharing data and escalating bugs and tooling issues to correct engineering teams with necessary documentation.

Implement pre-approved changes to workflows and knowledge repositories.

Help support and exchange knowledge with other PDO DLAs.

Strategic & Organized: Ability to manage multiple projects/workflows/ communication channels simultaneously.

Leadership in the face of ambiguity: Experience working independently, stepping up to address a problem even when not given clear instruction.

Tech: Experience with Excel; comfortable applying math to business decisions and large data sets; experience learning a new software platform independently.

Perform quality audits to provide labeling metrics and insights, support policy guideline updates, and recommend optimization opportunities across the labeling programs.