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Rep, Labeling Design

Irvine, CA 92618

Posted: 12/02/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 616305 Is job remote?: No Country: United States

Job Description

Target PR Range:  19-27/hr
*Depending on experience

Role Purpose
Process pre-designed changes by using labeling software.


Job Functions

Essential Job Functions
% of Time
Execute complex designed labeling changes (e.g., illustrations), using SDL and Loftware solutions. 65%
Evaluate risks, provide recommendations to management and take actions as necessary. 10%
Recommend process improvement opportunities that impact procedural updates and take actions as necessary 5%
Provide training and coaching to other design team members 5%
Support tasks related to NCR and CAPA activities 5%
Collaborate with labeling cross functional teams to design sustaining labeling changes. 5%

Marginal Job Functions
Percentage
Other incidental duties 5%

Combined Function Percentage 100

Qualifications

Education/Experience
Education Level Field of Study With Years of Experience Details Required Preferred
Associate's Degree or equivalent? 4 years of related work experience X or
H.S. Diploma or equivalent? 6 years of related work experience X

Licenses and Certifications
Enter Licenses/Certifications Lic/Certification Details Time Frame Required Preferred

Required Skills
• Good computer skills including usage of MS Office Suite
• Good knowledge of labeling design software (e.g., InDesign, Adobe Photoshop, Adobe Illustrator) required; CMS (Content Management System), Loftware Spectrum preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Good time management and organizational skills
• Ability to identify process improvement activities
• Able to read, comprehend, write, and speak English
• Full knowledge and understanding of policies, procedures, and requirements as it relates to task execution within labeling design
• Good knowledge of labeling requirements across business units
• Full knowledge of labeling systems and applications (e.g., ECR and PDM processes)
• Strict attention to detail
• Must be able to work in a team environment, including inter-departmental teams and other business units, under general supervision
• Provide feedback in a professional, direct, and tactful manner
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Additional Information
? Close and continuing supervision
? Little or no authority to deviate from established procedures
? Unusual questions are handed off to the supervisor to address and handle (as opposed to the employee continuing to have responsibility)
? Events not covered by procedures/instructions are referred to supervisor for disposition (as opposed to the employee continuing to have responsibility)
? Supervisor reviews progress and results for thoroughness


Education and Experience:
• Bachelor's Degree or equivalent
• Experience in medical/pharmaceutical FDA regulated industry required
• 2-4 years of experience required
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