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    Regulatory Affairs Specialist - Denver, United States - Insight Global

    Insight Global background
    Healthcare
    Description

    DAY TO DAY:

    Insight Global is looking for a Level II OR Sr. Regulatory Affairs Coordinator to join one of the largest oncology networks in the US. The candidate will open, track, and close studies being done within the cancer centers to understand the efficacy of drugs used to treat patients. This is a highly regulated environment, and the individual will need to be computer savvy, and have familiarity with regulatory terms, documents, and processes through phases 1,2, and 3 of the study. They will sit onsite for all 5 days during training (1-3 months) and then have the ability to be hybrid. The client is looking to bring someone on long-term. There will be growth opportunities within the organization relatively quickly if the candidate has enough experience.

    MUST HAVE:

    3+ Years experience with regulatory documents/studies within healthcare (feasibilities, Scheduling, SIV's - (SIV = Sight Initiation Visit to start a study)

    Able to handle 25+ studies at a time

    Able to open, maintain, and close a study with little supervision

    Familiar with the 3 phases of study (phase 1 = dosing, phase 2 = efficacy, phase 3 = comparison to standard treatment options within the industry)



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