Cardinal Health
Specialist I, Regulatory Submissions Operations - Document Management
At a glance
Location: US-KS-Overland Park Map
Posted: 10/16/2019
Closing: 11/15/2019
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
Cardinal Health
Job description

What Regulatory Submissions Operations contributes to Cardinal Health

Regulatory Submissions Operations is responsible for providing advanced formatting, proofreading, editing and compilation of paper and electronic documents related to the pharmaceutical industry throughout each phase of drug development; providing regulatory guidance and application submission and renewal service for state licensing activities; preparation of specialized electronic files for drug registrations, drug listings and self-identification; oversee and maintain document management database and version/revision control; electronic processing, publishing and compilation of documents and complete submissions according to regulatory specifications in support of regulatory applications with appropriate agencies.


Accountabilities

  • Administration of department document management cloud-based tool
  • Provide advanced formatting, proofreading, editing and compilation of paper and electronic documents related to the pharmaceutical industry throughout each phase of drug development
  • Electronic processing and compilation of documents and complete submissions according to regulatory specifications in support of regulatory applications with appropriate agencies
  • Assist Regulatory/Clinical project leaders to meet project timelines and client expectations

Qualifications

  • High school diploma or equivalent required
  • Bachelor’s degree or equivalent work experience in related field
  • Intermediate knowledge of Microsoft Word
  • Intermediate knowledge of Adobe Acrobat
  • Experience in document management tool administration or sub-administration
  • Demonstrates intermediate knowledge of preparation, formatting, copy, proof and compilation of documents included in regulatory submissions and other types of controlled documentation; produces deliverables at both the document level and at the dossier level
  • Proficient skills in spelling, grammar and punctuation
  • Minimum of one year in pharmaceutical industry is preferred
  • Project management experience is preferred

What is expected of you and others at this level

  • Applies basic concepts, principles, and technical capabilities to perform routine tasks
  • Works on projects of limited scope and complexity
  • Follows established procedures to resolve readily identifiable technical problems
  • Works under direct supervision and receives detailed instructions
  • Develops competence by performing structured work assignments

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.

Specialist I, Regulatory Submissions Operations - Document Management