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Job Field: Legal Jobs
Location: Valencia, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>LABELING SPECIALISTType:ContractLength:1-3 MonthsLocation:Valencia, CADescriptionOverview:Orbis Clinical s client has a phase III diabetes product for which they are modifying the label. They have already submitted a label for the NDA, but have not yet gone through label negotiations. They are exploring some unique options for the label and are seeking external advice as to what is acceptable/unacceptable and what this consultant has seen to be successful/unsuccessful.Position:Our client is in need of an experienced Labeling Specialist with labeling, cartridge, and carton experience. Consultant must have extensive experience with Regulatory guidelines pertaining to the label itself. Must be able to provide input into label design, i.e. print font size parameters, and what would be acceptable limits within regulation. Also to assist with content of label, including medication guide/guidance.They have a team who has labeling experience, they are looking for our consultant to offer insight from an outside source .Duration: On an as needed basis, 10-20 hours per month for 1-3 months, to be available for consultation.Skills/ExperienceRequirements:- Extensive experience with product labels. Simply working in a Labeling group is not sufficient experience, this person needs to have worked on the actual label itself (not package insert or other labeling materials).- Many years of experience working on multiple labels. Ideally endocrinology experience (Diabetes)- Experience with sections regarding dosage forms and strengths, description, and how it is supplied.- Familiarity with pharmacology/pharmacokinetics, clinical trials (efficacy) and/or CMCTo apply, please contact:Email:jobs@orbisclinical.com

KEY REQUIREMENTS:

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