Submission Publisher

for Mercom Group in Berkeley Heights, NJ

Report
Skills:
Submission Publisher 
Location:
Berkeley Heights, NJ
Area Code:
732 
Travel Req:
none 
Telecommute:
no 
Pay Rate:
Open 
Tax Term:
CON_CORP CON_IND CON_W2 CON_HIRE_CORP CON_HIRE_IND CON_HIRE_W2 
Length:
6+ months 
Posted:
7-16-2014 
Position ID:
216658 
Dice ID:
10110204 

Report/RA Submission Publisher

 

 

 

Overall responsibility:

 

  • Produces paper/electronic regulatory submissions (e.g., Clinical Study Reports, INDs, NDAs, MAAs, annual reports, routine submissions) in accordance with U.S. FDA and global requirements, using electronic publishing tools (Insight Publisher) and an EDMS system.
  • Interacts with the Medical Writing Department and with other functions to ensure publishing timelines are met.
  • Provides expertise on publishing and authoring activities.
  • Assists the Manager of Regulatory Submissions and Clinical Report Publishing Lead with projects as required.

 

Regulatory publishing responsibilities:

 

  • Publishes routine submissions prepared by RA Managers.
  • Conducts quality reviews and revises submissions.
  • Publishes Clinical Study Reports, annual reports, and INDs/NDAs/MAAs or portions thereof for assigned projects.

 

 

Knowledge

 

Requires knowledge of FDA/EMEA regulations and guidance for electronic and paper submissions and an understanding of the Clinical Study Report Requirements (ICH E3)

 

Skills

Working knowledge of Liquent Insight Publisher, Liquent eCTD Reviewer with Conformity Checker, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox is preferred.

Strong computer skills with demonstrated experience and ability in Documentum, Microsoft Office suite (Word, Excel, Access, and PowerPoint)

Keegan McCool
Mercom Group
8000 Sagemore Drive
Marlton, NJ 08053
Phone: (856) 983-1076
Fax: (856) 983-1176