Job Description

Job Title: Documentation Analyst

Location: New Brunswick, NJ (08903)

Duration: 6 Months (Possibility of extension for right candidate depending on performance)

Minimum 50% onsite required

Job Description :

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.

Job Qualifications :

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 :

Required: B.S. in Chemistry.

Preferred: M.S. or Ph.D. in Organic or Medicinal Chemistry.

Skills :

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

Job Tags

Similar Jobs