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
Attend the PRC meeting discussions to answer any editorial questions/concerns
Collaborate with marketing operations on prioritization for routine approvals as well as during major campaign launches and label updates.
Complete editorial review of promotional and non-promotional materials, final reviews, reapprovals and other review types as necessary
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
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Editor III · Mindlance