Job Title: Editor III
Location: REMOTE
Duration: 24 Months with possibility of extension
Job description:
Work shift (days/times) – 8:15 AM – 4:55 PM ; Mon-Fri
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?
EEO:
“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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