GRA Regulatory Delivery Excellence, Global Submission Publisher
Eli Lilly and Company · 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
- 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
Qualifications
- H.S. diploma AND 5+ years of Pharmaceutical Regulatory industry experience
- BS Degree in life science or computer science preferred
- Experience with CTD/eCTD structure and format
- Experience using eCTD compliant publishing system
- Three years of regulatory operations experience within a regulated environment
- Experience with Original IND and supplemental NDA/BLA eCTD submissions
- Strong knowledge of global health authority and ICH regulations and guidance
- Computer Skills: Proficiency with MS-Office Suite and Adobe Acrobat
- Broad technical knowledge (MS Word, Adobe Acrobat PDF Bookmarks and Hyperlinks, Acrobat Plug-ins, Document Management Systems, Excel, ISI Toolbox, Lorenz)