Scientist III, Chemistry, Mfg & Cntrl

Cardinal Health

Overland Park, KS 66210

Posted 2 weeks ago

Job Description

_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


_Qualifications_


+ 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_


+ Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects

+ May contribute to the development of policies and procedures

+ Works on complex projects of large scope

+ Develops technical solutions to a wide range of difficult problems\. Solutions are innovative and consistent with organization objectives

+ Completes work independently receives general guidance on new projects

+ Work reviewed for purpose of meeting objectives

+ May act as a mentor to less experienced colleagues


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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