Documentation Analyst

Overview

On Site
USD 40.00 - 42.00 per hour
Contract - W2

Skills

Recruiting
SAP BASIS
Manufacturing
Data Integrity
Marketing
Evaluation
Analytical Skill
Crystal Management Console
Attention To Detail
Problem Solving
Conflict Resolution
Documentation
Multitasking
Communication
Pharmaceutics
Chemistry

Job Details

Our client, a leading pharmaceutical company, is hiring a Documentation Analyst, on a contract basis.

Job ID #: 82163

Work Location:
New Brunswick, NJ - 50% Onsite

Summary:
This position involves compiling information from scientists, authoring the chemistry, manufacturing, and controls (CMC) sections of regulatory documents, and performing data integrity checks to support the timely submissions of both investigational and marketing applications for small and large molecules. This position requires the knowledge of fundamental principles of organic chemistry, the critical evaluation of analytical data, and it is preferred to have experience in drug substance and/or drug product CMC development.
The candidate should have excellent verbal and written communication skills and is expected to pay scrupulous attention to detail. This position requires constructive interactions with other members of a team to approach problem solving. Familiarity with computer-assisted document preparation tools is desirable.

Education/Experience:
  • Required B.S. in Chemistry. M.S. or Ph.D. in Organic or Medicinal Chemistry is strongly preferred

Knowledge/Skills:
  • Regulatory Documentation and/or Authoring experience (not just formatting)
  • Multitasking ability
  • Strong communication -oral and written
  • Pharmaceutical background
  • Strong organic or Medicinal chemistry

Pay Range: $40-$42/hr

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