Cardinal Health Scientist III, Chemistry, Manufacturing & Control in Philadelphia, Pennsylvania

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