GRA Regulatory Delivery Excellence, Global Submission Publisher
BioSpace · Indianapolis, IN · 1 mo ago
Marketing$63k–$150k/yrFull-time
Primary Responsibilities
- Execute submission workload
- Manage submissions
- Build on high level of expertise in electronic publishing
- Build technical and quality expertise
- Build Subject Matter Expertise within the Publishing Role and Process
- Train Assistant-Oversight of Submission Publishing Training program
- Asset Protection/Compliance
Duties
- Execute submission workload
- Manage submissions
- Prepare Submission Cover letters and forms
- Plan submission workload
- Retrieve, publish, and submit Module 1-5 reports/documents
- Submit and archive registrations
- Manage FDA Web trader account
- Manage submissions
- Build on high level of expertise in electronic publishing
- Build technical and quality expertise
- Build Subject Matter Expertise within the Publishing Role and Process
- Train Assistant-Oversight of Submission Publishing Training program
- Asset Protection/Compliance
Minimum Requirements
- H.S. diploma AND 5+ years of Pharmaceutical Regulatory industry experience
Additional Preferences
- BS Degree in life science or computer science preferred
- Knowledge of drug development process
- Previous experience working in the Pharmaceutical industry