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.
- Assist in the 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 preferred
- Ability to work with colleagues and multiple clients in a professional and organized manner, and interact effectively with a variety of people from different nationalities, ethnic/cultural backgrounds, and educational levels.
- Should be able to define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.
- Ability to organize and prioritize work with limited guidance and to manage projects in a timely and effective manner. Ability to reorganize and reschedule work on short notice in order to meet revised client deadlines.
- Manage and direct project team, including identifying, directing, and delegating tasks necessary for successful regulatory project completion.
- This is a remote work from home position
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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