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FDA Ad Material Regulatory Review Specialist [80085]
FDA Ad Material Regulatory Review Specialist [80085]Onward Search • North Chicago, IL, US
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FDA Ad Material Regulatory Review Specialist [80085]

FDA Ad Material Regulatory Review Specialist [80085]

Onward Search • North Chicago, IL, US
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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 routing
  • Collaborate 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 monitoring
  • Prepare materials, Form 2253, Cover Letter and send them over to Reg Operations for publishing and OPDP submission
  • Requirements :

  • Bachelors Degree in Technical, Regulatory, or Science Related Discipline.
  • Good organizational and time management skills.
  • Strong communication, both oral and written
  • Proficient 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 plus
  • Perks & Benefits :

  • Medical, Dental, and Vision Insurance
  • Life Insurance
  • 401k Program
  • Commuter Benefit
  • eLearning
  • Education Reimbursement
  • Ongoing Training & Development
  • To 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.

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    Regulatory Specialist • North Chicago, IL, US

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