Job Number: 20015346
Date Posted: 7-22-2017
Job Title: Scientist III, Chemistry, Manufacturing & Control
What Scientific Consulting contributes to Cardinal Health
Scientific Consulting is responsible for Pharmaceutics, Chemistry, Microbiology and other Biotechnology and Life-science related disciplines performing basic and applied research to provide innovative solutions for internal and customer funded projects.
Accountabilities in this role
• Manages assembly of regulatory information for submission
• Adheres to the client’s defined submission preparation timelines
• Searches document and change management databases for historical
data/information that need to be captured in the updated regulatory submission.
• Using the client’s templates for dossier sections, author CMC sections for routine
submissions (e.g., clinical trial amendments, Type I variations, IND/NDA/BLA
annual reports, CMC renewals), including adding technical data and descriptive text
• Collaborate with Data Verification Specialist to have submission content verified
• Liaise with Senior Submission Preparation resource to have work product reviewed
• Bachelor's degree required
• Minimum 2 years related experience
• Foundation in general scientific practice and in the principles and concepts of a discipline (e.g., chemistry, pharmaceutical science, pharmacy, biology, microbiology etc.)
• Sound knowledge of several aspects of regulatory principles, practices and concepts applicable to preparing regulatory submissions
• Rudimentary understanding of drug development or manufacturing/improvement processes
• Understands regulatory merits for scientific/technological development or manufacturing activities
What is expected of you and others at this level
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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