Editor

Job Title: Editor IIILocation: REMOTEDuration: 24 Months with possibility of extension Job description:Work shift (days/times) – 8:15 AM – 4:55 PM ; Mon-FriJob DescriptionResponsibilities: 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 EEO:“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”