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| | | HOT JOBS:
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| Full Time Permanent |
1. Practice Manager - Regulatory Affairs and Submissions - Pharma
New York
Details of the position and Qualified Candidate should be familiar with the following:
· Knowledge of regulatory affairs
processes common across the industry
· FDA regulations and guidances for regulatory submissions
· Awareness of regulatory initiatives in other regions
such as Europe, Japan, Brazil, Canada, Australia
· Global product information and labeling practices and emerging trends in the industry
· Best practices
in regulatory affairs information management
· Understanding of document management requirements such as 21 CFR Part 11 compliance requirements, validation, workflow/lifecycle, electronic signatures
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Emerging electronic submissions standards, practices, and regulations regarding eCTD, SPL, CDISC, and the role of XML
· Protocol development and emerging trends in the industry
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Leading solutions for document management, publishing, submission preparation, process management, tracking and collaboration2. DOCUMENTUM - New York Multiple positions
 | Program Manager |
| Project Manager |
| Business Analysts |
| Application Architects |
| Software Engineers |
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| CONTRACT POSITIONS |
1. Firmware Engineer
| Embedded firmware engineer |
| Experience in assembly, C, C++ |
| Experience in u-controller |
| with u-chip PIC u-controllers preferred |
| Fluent with MakeFile or similar build processes |
| Experience with CVS preferred |
| Experience with integration and debug of multi-contributor systems |
| Experience in networking protocol preferred |
| Experience in Set Top Box would be a bonus |
| 5 years experience |
2. SAS/ Pharma
3. Informatica, Business Objects Pharma |
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