Proofreader Labeling Jobs in San Francisco, California

8+ years of program / project management experience

Manage a team of highly skilled program and project managers

Strong track of organizational management, budgeting, and resource management

Manage our multi million dollar budget from planning to monthly reporting in alignment with our quarterly forecast

Manage our vendors and negotiate contracts

A seasoned people manager with a passion for growing others

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

• Create and modify data labels ensuring compliance to all regulatory and legal requirements.

• Excellent communication skills, verbal and written.

• Bachelors degree in related field.

• Maintain batch records, room logs, product travelers, and inventory records.

• Label and analyze large data sets to inform product decisions.

• Ability to identify trends within large data sets.

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

• Experience with data annotation tools and techniques

• Familiarity with red teaming

• 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

• 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

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

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.

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 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.

Prior knowledge/experience to work with labeling systems (e.g. PRISYM)

An Associates degree preferred; or two years of equivalent on the job training/experience is required or

Bachelor's Degree with 1 year of related experience

Understanding of medical device labeling requirements, regulations and industry standards

Previous experience working in a medical FDA regulated industry

Excellent computer skills including usage of MS Office Suite

Proven successful project management leadership skills

Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

Develop team members to increase business acumen and functional skills.

Bachelor's Degree and related Labeling experience

Master's Degree and 6-8 years of related Labeling experience

Experience working in medical device, pharmaceutical or FDA regulated industry

Strong interpersonal, project management, communication, negotiation and problem solving skills.

Represent GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products.

Serve as the labeling lead for all labeling related topics.

Present to GLC on CDS changes.

Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.

Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries

Join Takeda as a Sr Manager., Global Labeling (Remote)

Authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products.

Strong oral and written communication, managing and adhering to timelines, negotiation skills, integrity, and adaptability.

What Takeda can offer you:

Leads cross-functional teams to develop and update CCDS and other key global labeling documents (i.e. CCDS Working Team).

Provides labeling strategy and guidance to Local Operating Company (LOC) Regulatory, in collaboration with the RA Sub team.

Manage sample tubes and prepare for shipment; appropriately manage any exceptions, and ensure products are suitable for release to distribution.

Prioritize workload to meet production and customer requirements.

Analyze and make decisions based on visual inspection and information provided from other departments to meet time requirements and quality standards.

Good computer skills, attention to detail, accurate documentation, and good decision-making skills.

Good communication skills. Ability to work on a team.

Manufacture, label, and store blood products according to applicable Red Cross policies and procedures.

Top 3 must-have HARD skills:

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

5. Must have 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

Devising new methods for circumventing the protections in AI language models

Manage sample tubes and prepare for shipment; appropriately manage any exceptions, and ensure products are suitable for release to distribution.

Prioritize workload to meet production and customer requirements.

Analyze and make decisions based on visual inspection and information provided from other departments to meet time requirements and quality standards

Good computer skills, attention to detail, accurate documentation, and good decision-making skills.

Good communication skills. Ability to work on a team.

Manufacture, label, and store blood products according to applicable Red Cross policies and procedures.

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.

· “From -> To” redline creatio

The ideal support should cover these bases:-

· Onsite availability would be a nice to have for better collaboration when needed

The CAD/drawing work itself includes:-

· Conversion of critical dimension callouts to a new convention

Prior knowledge/experience to work with labeling systems (e.g. PRISYM)

An Associates degree preferred; or two years of equivalent on the job training/experience is required or

Bachelor's Degree with 1 year of related experience

Understanding of medical device labeling requirements, regulations and industry standards

Previous experience working in a medical FDA regulated industry

Excellent computer skills including usage of MS Office Suite

1 –3 years’ experience in data annotation or labeling preferred

A person with excellent reading comprehension, analytical skills, and passion for data

Computer literacy and virtual work skills are expected.

Background in financial markets and knowledge of key concepts

Medical, dental, vision, life insurance, and other ancillary benefits

Use specialized software to label data in multiple formats.

Job Location: Tampa, FL (Fully Remote)

·Additionally, he/she is responsible for data entry, data tracking and assisting with document distribution globally.

·Electronic proofreading software experience, a plus.

·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.

·Experience in proofreading, including prescription drug labeling

SkillsQualifications:Bachelor’s degree (Science or English) preferred

Responsible for data entry, data tracking and assisting with document distribution globally.

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

Experience in proofreading, including prescription drug labeling

Prior experience with electronic proofreading tools a plus

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.

Experience in proofreading, including prescription drug labeling.

Prior experience with electronic proofreading tools a plus.

Spanish, or other international market proofreading capabilities will be an advantage.

Additionally, he/she is responsible for data entry, data tracking and assisting with document distribution globally.

US military experience will be considered towards industry experience requirements.

Manages external requests for country specific labeling information (e.g. medical content, pharmaceutical properties) from various source or reference documents.

Maintains an understanding of regulatory labeling requirements of assigned region or countries.

Must possess an excellent command of language (English) and professional knowledge of medical terms,

Experience working on multi-disciplinary teams and projects

Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)

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.

Strong computer, organizational, and project management skills.

Contributes to the completion of all technical and operational activities for Labeling Operations projects through management of internal and external resources.

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

Owns quality records such as CAPAs, Deviations, and Change Management related to labeling.

Strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents.

Evaluates the flow of projects through the artwork development process against established timelines and prioritizes activities based on changing requirements.

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.