Labeling Proofreader Jobs

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

• 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.

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

Provide additional support for certification programs

Education: Bachelor’s degree in Food Science, Chemistry, Biology, or related fields

Experience: Minimum 1 year of responsibility in food or supplement industry and/or supplemental regulatory role

Knowledge of regulatory affairs, quality documentation, and business processes (stage gates)

Excellent communication skills, both written and oral

Experience with ESHA Genesis is preferred but not required

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.

Education, Knowledge, Skills, & Abilities

Self-directed with excellent time management skills.

Responsible for measuring costs associated with each initiative as well as the management of the Product & Package Development budget.

Bachelor’s degree in Design, Visual Arts, Packaging or similar discipline is required. OTC packaging experience a benefit.

Manage routing process including feedback from clients and resolving issues, preflight projects, including review of proofs, color correction and production changes.

Manage complex projects and deliver innovative packaging solutions within the appropriate timelines.

· “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

Functional/Technical Knowledge, Skills and Abilities

Commitment to learn and stay abreast of global medical devices regulatory requirements.

Minimum 7 years' experience in related work experience

Experience with regulatory documentation is preferred

Excellent communication and interpersonal skills

Serve as company-wide labeling SME working with various workstreams to maintain compliant labeling needs.

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)

• 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