What are the responsibilities and job description for the Documentation Analyst (NO C@C) position at Systems Ally?
Strictly no C2C
New Brunswick, NJ
Minimum 50% onsite required
Duration:6 months(Possibility of extension for right candidate depending on performance)
Strong organic or Medicinal chemistry
Required B.S. in Chemistry. M.S. or Ph.D. in Organic or Medicinal Chemistry is strongly preferred Job Description: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. M.S. or Ph.D. in Organic or Medicinal Chemistry is strongly preferred
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 Type: Contract
Pay: $40.00 per hour
Expected hours: 40 per week
Benefits:
- Health insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
- cmc: 5 years (Required)
- drug product: 5 years (Required)
Work Location: On the road
Salary : $40