Medical Editor (AMA)

Job Description

The Planet Group  is seeking a Medical Editor  to join one of our well-known global pharmaceutical clients.  \n
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• Pay : $41-46.90/hr depending on experience 
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• Location : Hybrid in Mettawa, IL (T-TR onsite)
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• Duration : 2 years
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• Manage review and approval process for promotional, non-promotional and internal use materials
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• Manage electronic approval system, user access, user training and workflows
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• Support FDA Ad Promo Submissions
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• Support QC and regulatory reviews of the materials
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• Coordinate promotional and non-promotional materials review and approval processes
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• Maintain in-depth knowledge of approval process routing grids per SOP and route the materials for approvals accordingly
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• Attend the PRC meeting discussions to answer any editorial questions/concerns
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• Collaborate with marketing operations on prioritization for routine approvals as well as during major campaign launches and label updates
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• Complete editorial review of promotional and non-promotional materials, final reviews, reapprovals and other review types as necessary
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• Archive OPDP correspondence per guidance from Reg Ad promo lead
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• Contribute to development and update of departmental work instructions
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• Prepare materials, form 2253, cover letter and send them over to Reg Operations for publishing and OPDP submission
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• Support other departmental initiatives as needed (e.g. process improvements)
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• Bachelors degree in technical or science related discipline or related work experience
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• Preferred: 3 years in regulatory, quality or related area
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• Highly detail oriented, and great communication skills, able to work independently as needed
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• Experienced medical editing
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• Fact checking of medical materials
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• Proactive about seeking out work when presented with downtime
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• Ability to pivot or shift gears quickly, working in a high volume, fast-paced environment
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