Promotional Review Coordinator (PRC)

Job Description

Position Details:

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Job Title: Promotional Review Coordinator (PRC)

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Location: Mettawa, IL

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Duration: 12+ Months (Possible extensions)

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Description Details

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Responsibilities: Manages review and approval process for promotional, non-promotional and internal use materials. Manages electronic approval system, user access, user training and workflows. Supports FDA Ad Promo Submissions. Supports 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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Years of experience/education and/or certifications required:

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•Bachelor’s 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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EEO:

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“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans. ”

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