Documentation Analyst

Company: Joul--
Location: New Brunswick
Posted on: April 5, 2025

Job Description:

Job Title: Documentation Analyst

Do not wait to apply after reading this description a high application volume is expected for this opportunity.
Location: New Brunswick, NJ (Hybrid 50% onsite)
Type: Contract

Overview
Leading pharmaceutical company looking for an experienced Documentation Analyst. Ideal candidates should have at least a bachelor's degree and experience with authoring regulatory documentation in a pharmaceutical company.

Responsibilities 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.


Requirements Required B.S. in Chemistry. M.S. or Ph.D. in Organic or Medicinal Chemistry is strongly preferred
Regulatory Documentation and/or Authoring experience (not just formatting)
Multitasking ability
Strong communication -oral and written
Pharmaceutical background
Strong organic or Medicinal chemistry



Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.


Ref: #568-Clinical

Keywords: Joul--, New Brunswick , Documentation Analyst, Professions , New Brunswick, New Jersey