Telecommute Senior Regulatory Publisher

Job Summary

A clinical research organization is searching for a person to fill their position for a Telecommute Senior Regulatory Publisher.

Core Responsibilities of this position include:

• Formatting, publishing (including QC), transmitting and archiving of regulatory submissions
• Participating in sub-team meetings, volunteering for action items and participating in issue resolution
• Troubleshooting and resolving issues with critical computer application systems

Required Skills:

• At least 3 years of experience in regulatory operations
• An advanced understanding of regulations and guidance associated with submissions
• Proficiency in MS Office 2013, Adobe Acrobat and knowledge of eDMS
• Ability to answer technical questions for many submission types
• Experience with electronic submissions