| Go back to last page |
|
Regulatory Submissions Manager
|
|
| Department: |
Clinical Development |
|
| Date Posted: |
05/09/2008 |
|
| Location: |
The Woodlands, TX |
|
| Reference: |
RSM 23165 |
|
Job Description: |
This position is responsible for managing and maintaining existing IND/CTA submissions and preparing amendments and annual reports in compliance with FDA regulations. Responsibilities will include, but will not be limited to: working with CROs for ex-US submissions; coordinating with functional leads in various disciplines to assemble documents including writing, reviewing, editing and publishing submissions; assisting with pre-IND meeting briefing packages and initial IND submissions for new programs; representing the department on multi-disciplinary development sub-teams; mentoring personnel; and other duties as assigned or required. |
|
| Qualifications: |
- Bachelor’s degree in a scientific discipline
- Minimum of five (5) years experience in a regulatory position within a biotech, pharmaceutical or clinical research organization
- Experience with electronic filing submissions preferred
- Excellent organization and communication skills
- Ability and desire to work in a team-oriented environment
|
|
Lexicon's Benefits
Lexicon Pharmaceuticals is an equal opportunity employer. |
|
|
