Title
Labeling Specialist
Under general supervision, responsible for the development, design, proofreading, typesetting and editing of the company’s generic and branded pharmaceutical labeling. Responsible for the preparation of the labeling section for regulatory submissions.
Essential job functions:
• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Develops, designs, typesetting and editing of generic and branded pharmaceutical labeling (cartons, container, vial labels, foils, sleeves, tubes and stickers) for existing and new products.
• Proofreads internal and external material to ensure accuracy of labeling content and company format.
• Communicates internally and externally to acquire necessary information to complete projects. Tracks and manages all external labeling correspondence.
• Prepares insert artwork for new and existing company products based on current labeling of the drug. Reviews inserts to ensure compliance and accuracy.
• Provide labeling status reports when requested to management.
• Provide assistance and or training to other department staff members in reference to the graphics program that is used to develop and revise labeling artwork files.
• Ensures project deadlines and performance standards are established and met.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Performs related duties as assigned.
Bachelor’s Degree from an accredited college or university, and four (4) to six (6) years pharmaceutical industry experience, two (2) of which must be Regulatory experience, or an equivalent combination of education and experience.
Knowledge of:
• Food and Drug Administration (FDA) regulations and guidelines.
• Current FDA/Regulatory Affairs submission requirements.
• Logistics and work of the pharmaceutical industry.
• Business, scientific and personal computer hardware and software applications.
• Business English usage, spelling, grammar and punctuation.
• Current Company policies, practices and procedures, including safety rules and regulations.
Labeling Specialist
Under general supervision, responsible for the development, design, proofreading, typesetting and editing of the company’s generic and branded pharmaceutical labeling. Responsible for the preparation of the labeling section for regulatory submissions.
Essential job functions:
• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Develops, designs, typesetting and editing of generic and branded pharmaceutical labeling (cartons, container, vial labels, foils, sleeves, tubes and stickers) for existing and new products.
• Proofreads internal and external material to ensure accuracy of labeling content and company format.
• Communicates internally and externally to acquire necessary information to complete projects. Tracks and manages all external labeling correspondence.
• Prepares insert artwork for new and existing company products based on current labeling of the drug. Reviews inserts to ensure compliance and accuracy.
• Provide labeling status reports when requested to management.
• Provide assistance and or training to other department staff members in reference to the graphics program that is used to develop and revise labeling artwork files.
• Ensures project deadlines and performance standards are established and met.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Performs related duties as assigned.
Bachelor’s Degree from an accredited college or university, and four (4) to six (6) years pharmaceutical industry experience, two (2) of which must be Regulatory experience, or an equivalent combination of education and experience.
Knowledge of:
• Food and Drug Administration (FDA) regulations and guidelines.
• Current FDA/Regulatory Affairs submission requirements.
• Logistics and work of the pharmaceutical industry.
• Business, scientific and personal computer hardware and software applications.
• Business English usage, spelling, grammar and punctuation.
• Current Company policies, practices and procedures, including safety rules and regulations.