Editor III

Position Title Editor III Location/Site US-IL-Lake County (ABV1, 26525 North Riverwoods Boulevard) (S3929) Duration 2 Year Work shift (days/times) 8:15 AM 4:55 PM 100% Onsite Payrate: $48.00 - $49.00/Hour Job Description 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. " Coordinate promotional and non-promotional materials review and approval processes " Maintain in-depth knowledge of approval process routing grids per SOP and route the materials for approvals accordingly " Perform Quality Check review on the materials prior to routing " Collaborate with sponsors and agencies to develop and plan PRC meeting agenda " Facilitate the PRC meeting discussions and document outcome in live meetings while conducting meeting efficiently to cover the full agenda " Collaborate with marketing operations on prioritization for routine approvals as well as during major campaign launches and label updates. " Complete regulatory review of promotional and non-promotional materials, final reviews, reapprovals and other review types as necessary " Develop and update training resources on materials review process and Veeva functionality. Train sponsors, agencies, and reviewers as needed " Manage user profiles, training needs and access to the VeevaPromomats to sponsors, agencies, and reviewers " Serve as a point of contact to Veeva vendor for ongoing maintenance and optimization of Veeva workflows. Assist with Veeva Promomats IT validation " Generate Veeva metric reports to help with process improvement, resource management and compliance monitoring " Archive OPDP correspondence per guidance from Reg Ad promo lead " Contribute to development and update of departmental work instructions " Prepare materials, form 2253, cover letter and send them over to Reg Operations for publishing and OPDP submission " Support other departmental initiatives as needed (e.g. process improvements) Years of experience/education and/or certifications required: "Bachelor s degree in technical or science related discipline or related work experience "Preferred: 3 years in Regulatory, Quality or related area What are the top 3-5 skills requirements should this person have?Document-Quality CheckGood organizational and time management skillsStrong communication, both oral and writtenAbility to innovate, analyze, understand customers needs with minimal supervisionProficient with computer systems and/or pharmaceutical softwareExperience in a complex and matrix environmentExperience in pharmaceutical industry preferredPast experience in prescription drug advertising/promotional labeling and/or promotional labeling submissions desiredKnowledge of procedures and requirements regarding prescription drug advertising and promotional materials desiredProficient with computer systems and/or pharmaceutical softwareScience background is a plus