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Pharma Job USA | Clinical Regulatory Affairs Associate @ Ascent

Pharma Job USA | Clinical Regulatory Affairs Associate @ Ascent

Pharma Job USA | Clinical Regulatory Affairs Associate @ Ascent: Ascent invests a tremendous amount of time and money to ensure that we provide value to our client and industry relationships. Our CEO often tells clients that before they select a vendor they should leverage the knowledge of their peers at other companies in the industry. To help facilitate this, Ascent founded three of the fastest growing professional associations that are discipline specific, cost nothing to participate in and are exclusively for buyer practitioners who are employees of enterprise clients. These associations are: Project Portfolio Management Professionals (PPMP), Data Management Professionals(DMP) and Contingent Workforce Management Professionals (CWP).

Pharma Job USA | Clinical Regulatory Affairs Associate @ Ascent

JOB RESPONSIBILITIES:

  • Liaises with global affiliate sites to maintain up to date global labeling information in the global labeling repository (GLS)
  • Performs quality control of information entered by Analysts into the global labeling repository (GLS)
  • Performs proactive data remediation in global labeling repository (GLS) to ensure accurate and up to date labeling information is captured
  • Partners with Registration Management and Regulatory Information Services
  • Partners with Global Submissions Operations to ensure all affiliate labeling needed for regulatory submissions is available in the global labeling repository (Pending Submissions)
  • Provides labeling process training to global affiliate sites
  • Assists to establish process and standards related to the global labeling repository (GLS)
  • Functions as subject matter expert for global labeling and related functional areas
  • Communicates global labeling regulatory requirements as it pertains to the global labeling repository (GLS), to department and other cross-functional areas

QUALIFICATIONS

  • Bachelor degree preferred in a scientific and/or computer science discipline
  • 4+ years of pharmaceutical, regulatory and labeling experience in a global regulatory environment or equivalent
  • 3+ years of experience with electronic document management technology or equivalent demonstrated knowledge
  • Demonstrated analytical capabilities
  • Demonstrated strong communication skills, effective presentation skills, negotiation and influencing skills
  • Consulting and Glemser xmLabeling experience is a plus
JOB TITLE:Clinical Regulatory Affairs Associate
JOB TYPE:Contract
DATE UPDATED:July 22, 2016
LOCATION:Abbott Park, IL
JOB ID:16-05300

Pharma Job USA | Clinical Regulatory Affairs Associate @ Ascent

How to apply: http://www.ascentsg.com/job/16-05300/contact

View Original Notification:  http://www.ascentsg.com/jobs/n-a/clinical-regulatory-affairs-associate-1?SID=INDORG

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