Onward Search is a specialized staffing and talent solutions company that helps professionals find top jobs with the nation's leading brands.
We're looking to hire a Regulatory Review Specialist for a our client who is a global biopharmaceutical company based in North Chicago, Illinois.
You'll join the FDA Ad Promo Submissions Material Team to manage review and approval process for promotional, non-promotional and internal use materials as well as electronic approval system, user access, user training and workflows.
- This is a 12 + month opportunity.
- The role is located in Mettawa, Illinois and is hybrid onsite
- Hourly Pay : $50hr.
Responsibilities :
Coordinate promotional and non-promotional materials review and approval processes.Maintain in-depth knowledge of approval process routing grids and route the materials for approvals.Perform Quality Check review on the materials prior to routingCollaborate with Sponsors and Agencies to develop and plan PRC Meeting Agenda.Collaborate with Marketing Operations on prioritization for routine approvals and complete the Regulatory Review of promotional and non-promotional materials, final reviews.Manage user profiles, training needs and access to Sponsors, Agencies, and Reviewers.Serve as a point of contact to Veeva Vendor for maintenance and optimization of workflows.Generate Veeva Metric Reports to help with process improvement, resource management and compliance monitoringPrepare materials, Form 2253, Cover Letter and send them over to Reg Operations for publishing and OPDP submissionRequirements :
Bachelors Degree in Technical, Regulatory, or Science Related Discipline.Good organizational and time management skills.Strong communication, both oral and writtenProficient with computer systems and / or pharmaceutical software including Veeva.Experience in Pharmaceutical Industry preferred, experience in prescription drug advertising / promotional labeling and / or promotional labeling submissions desired.Science background is a plusPerks & Benefits :
Medical, Dental, and Vision InsuranceLife Insurance401k ProgramCommuter BenefiteLearningEducation ReimbursementOngoing Training & DevelopmentTo qualify for our benefits package, you must work over 30 hours per week and the length of assignment must be a minimum of 10 weeks.To learn more about this opportunity, apply now. Our Recruitment Team will be in touch, guide you through the interview process, and advocate on your behalf.