What are the responsibilities and job description for the Documentation Analyst position at System One?
Job Title: Documentation Analyst
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
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
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.
- 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
