Documentation Specialist

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