Job Summary
A staffing agency is seeking a Remote Biopharmaceutical Regulatory Publisher.
Individual must be able to fulfill the following responsibilities:
- Manage all stages of submission management
- Provide preparation, scanning, rendering, hyperlinking and bookmarking
- Peer Reviewing documents
Applicants must meet the following qualifications:
- 3-4 years of experience in Regulatory Publishing and reviewing documents in a pharmaceutical environment
- Experience with Safety Submissions and publishing Clinical Study Reports
- Must be an expert with the eCTD submission process in using different applications like viewpoint
- Knowledge in FDA and ICH guidelines
- Experience in Document Management Systems (example, Livelink, Documentum)
- Knowledge is preparing paper submission, scanning documents and printing desk copies
