Hikma Pharmaceuticals USA Inc.

  • Columbus College Summer Intern - Drug Regulatory Affairs

    Job Location US-OH-Columbus
    Posted Date 2 days ago(5/18/2019 11:04 AM)
    Job ID
    2019-5179
    Job Function
    Regulatory Affairs
    Shift
    Columbus First Shift
  • Overview

    Hikma Pharmaceuticals is currently seeking talented College Summer Interns for our Columbus, Ohio facility. As an Intern you will establish and maintain meaningful projects in a working environment that will enhance your marketability as well as provide value to the organization through continued networking.   You will actively contribute to the discovery, development and delivery of our products to our patients and customers.

    Responsibilities

    • Participate in formulation of regulatory strategy, assist in compilation of regulatory submissions, including chemistry, manufacturing, and controls (CMC), labeling, medical sections of a submission.
    • Participate in clinical study program review and management
    • Participate in REMS program management and submissions
    • Review and interpretation of FDA guidances, and creation of associated training presentations
    • Participate in other departmental functions, as needed

    Qualifications

    Preference will be given to students who are incoming juniors or seniors with a cumulative GPA above 3.0.

    Scientific professional with an interest in regulatory technical data review and clinical study project management. MS Office and other computer skills, proficient in scientific article review and evaluation, sound understanding of US FDA regulations and guidances translating into interpretation and implementation into projects.

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