Labeling Coordinator 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

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.

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.

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