International Labeling Specialist Jobs

Conduct high level proof-reading capabilities.

Maintain current knowledge of U.S. FDA submission standards.

Normal office situation or remote.

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

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

The responsibilities of this position may include, but are not limited to, the following:

Master and Executed Batch Record review and resolution of comments/issues

Archiving of batch documents in electronic document system

Track data for the purpose of metrics generation

Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status

Disposition Decision and status change in Oracle

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.

Strong computer skills and technical troubleshooting abilities

Work remotely from the comfort of your own home

Answer complex inbound account inquiries and provide advanced knowledge of Visa, Retail, Debit, Loyalty Program, and Gift Card products

1+ years of customer service experience

Excellent communication skills, both verbal and written

Ability to handle a high volume of calls with accuracy and deliver excellent customer experiences

· “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

Strong numerical, analytical, and problem-solving approach, with advanced project management experience.

Participate in various audits and risk management processes on an ongoing basis and manage/ensure accurate and timely regulatory filings.

Provide compensation and benefits consultation and advice to business leaders, clients, and partners to support business priorities.

Ensure compliance with all relevant compensation and benefits regulatory frameworks and related procedures.

Outstanding communication, influencing and partner relationship skills

External consulting experience would be a plus.

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.

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

This contractor position will be responsible for the following:

Bachelor’s degree or equivalent years of experience in a technical or business discipline

2+ years of relevant work experience required.

Leading candidates will possess one or more of the following experiences:

Utilize quantitative skills to analyze complex data, interpret results, provide recommendations, and communicate in a clear and concise manner.

Experience working with International teams

Working knowledge of PRISM, RPAD, SAS, Diio, Hyperion, Tableau, and similar business intelligence tools preferred

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)

Bachelor of Science in a technical science-related field of study or international affairs/relations plus 8-10 years of relevant experience, MS desired.

Excellent oral and written communication skills. Able to effectively communicate with senior leadership.

Experience in DOD, the Defense Threat Reduction Agency or a similar military staff

Experience working or coordinating with US Embassy Country Teams; Defense Attaché Office

Experience developing, staffing, or managing partnership / international agreements

Participate in NATO panels to establish international collaborative research, lecture seminaries, and long-term studies pertaining to chemical and biological defense.

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.

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.

·Manage and scope out multiple labeling projects in a highly cross-functional environment.

·Experience working independently and a track record of taking initiative

·Experience working with large data sets and keeping the quality high.

·Experience in Excel and/or SQL

·Impeccable communication and relationship-building skills

·Drive labeling workflows and projects success metrics and timeline.

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.

Prior experience in project management and demonstrated success in collaboration with individuals and diverse teams.

Experience working in higher education with a focus on international education.

Knowledge of common computer application programs used in higher education settings.

Bachelor's degree in related area and / or equivalent experience / training.

Demonstrated successful experience in event and/or program planning and promotion for international students, international scholars, and/or other constituencies.

Skills in judgment and decision-making and problem solving for unanticipated events.

Knowledge of Agile Software Document Management Solution.

Good analytical and problem-solving skills

Strong written and oral communication skills

Working on Service manuals, IFUs, knowledge of medical symbols

Basic knowledge of QSR/GMP (preferred).

Basic experience w/ print publishing, design, or document control programs.