I can finally reveal the true explanation for the delay in filing the BLA. <g>
In the jobs-available listings at Biospace:
Coulter Pharmaceutical, Inc.
Title
Electronic Submission Specialist
Location
South San Francisco, California, U.S.A.
Description
This is an exciting time for you to team up with Coulter Pharmaceutical, a leading developer of novel drugs and therapies for the treatment of cancer and auto-immune diseases. Our most advanced investigational biologic product candidate is Bexxar (tm), a targeted, micro-radiation therapeutic being developed for the treatment of non-Hodgkin's lymphoma and other B-cell based malignancies.
We are looking for a motivated professional to apply their expertise and vision to help us build, not only a leading pharmaceutical company, but the future of novel cancer therapeutics. As a key member of CPIs multi-functional submissions team, the ideal candidate will manage and process large documents supporting regulatory submissions.
Duties:
Responsible for typing, editing, proofing, creating, and manipulating complex tables, converting text (between various platforms), converting graphics, and scanning.
Lead Operator on electronic publishing system (CoreDossier tm).
Review and analyze regulatory records to ensure completeness and accuracy.
Complete special projects as needed.
Qualifications
At least 4 years of Desktop Publishing experience.
Proficiency using MS Office, publishing experience (preferable ESPS CoreDossier tm), desktop systems with an ability to learn new applications, or procedures quickly.
Excellent organizational skills, ability to work with minimal supervision.
Excellent interpersonal and team member skills a requirement.
Familiarity with regulatory submissions and guidelines, and/or experience in a document production environment, particularly in the pharmaceutical/scientific industry.
Peter |
