- Pay: $41-46.90/hr depending on experience
- Location: Hybrid in Mettawa, IL (T-TR onsite)
- Duration: 2 years
- Manage review and approval process for promotional, non-promotional and internal use materials
- Manage electronic approval system, user access, user training and workflows
- Support FDA Ad Promo Submissions
- Support 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)
- Bachelors degree in technical or science related discipline or related work experience
- Preferred: 3 years in regulatory, quality or related area
- Highly detail oriented, and great communication skills, able to work independently as needed
- Experienced medical editing
- Fact checking of medical materials
- Proactive about seeking out work when presented with downtime
- Ability to pivot or shift gears quickly, working in a high volume, fast-paced environment