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 Business Analyst (Regulatory Asset Manager)  
Ref No.: 17-00073
Location: New Jersey, New Jersey
Position Type:Contract
Start Date: 02/22/2017
Business Analyst (Regulatory Asset Manager)  
  • Minimum of 7-9 years’ experience in a pharmaceutical company as Business Analyst
  • Understanding of regulatory domain experience with Regulatory Asset Manager and LAB system
  • Extensive knowledge using Blue Mountain RAM, especially Admin. Knowledge of Empower 2 is a plus.
  • Ability to perform regulatory review with regulatory affairs and legal department to ensure accuracy and compliance
  • Working experience of Empower 2 as end user
  • Strong knowledge of GxP Laboratory data system including understanding on protocol execution, electronic records and electronic signature
  • Good understanding on business need to bridge the gap between business users and technologists
  • Ability to understand large complex processes with a focus on continuous improvement via thought leadership
  • Strong technical writing skills and analytical skills 
  • Strong networking abilities and an ability/willingness to work with individuals globally 
  • Pharmaceutical Regulatory Business Analyst
  • Must have experience on Regulatory Asset Manager, Lab Systems, Empower and GxP