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Non-Clinical Study Manager II, Pharmacological Sciences

Company: Meet
Location: San Rafael
Posted on: January 15, 2022

Job Description:

Non-Clinical Study Manager II, Pharmacological Sciences - San Rafael, CaliforniaSummary:Exciting opportunity in non-clinical study management! Meet is partnering with the world leader in delivering therapeutics that provide meaningful advances to patients who live with life-threatening rare genetic diseases. In this role you will be responsible to manage all activities required for the design, execution, and completion of non-clinical pharmacology and toxicology studies conducted with CROs. These activities include study planning, coordinating test material transfer, ensuring adherence to the protocol, managing study documents and data, and finalizing the study report as well. You will ensure the compliance with the current GLP (Good Laboratory Practice) regulations. You will also directly support the regulatory IND-filing as well by providing study reports and reviewing non-clinical regulatory documentsJob Responsibilities:

  • Manage all aspects of GLP and non-GLP non-clinical pharmacology, toxicology, and PK studies
  • Ensure that study activities are consistent with the protocol, study objectives, and project strategy.
  • Develop, track, and ensure adherence to study timelines
  • Prepare sections, of the regulatory written summaries and assist in the review of various regulatory documents. - Develop and maintain relationships with study directors, principal investigators and other external collaborators.Skills Required:
    • Minimum: Bachelor's in Biological Sciences or closely related field of study.
    • 5+ years of experience in a pharmaceutical, biotechnology, or contract research organization or equivalent.
    • General understanding of GLP regulations
    • Excellent organizational, operational and computer skills including attention to detail/documentation, the ability to learn quickly, and the ability to manage multiple projects/tasks simultaneously.
    • Ability to foster and maintain professional relationships with internal and external collaborators to complete the given tasks.Contact Details:The full job description and company details are available upon application. This position is being handled by Jack at Meet, call +1 415-354-2987 or email directly at jack.delaney@peoplewithchemistry.com to discuss further and in confidence.You can find more about Jack and Meet online at www.peoplewithchemistry.com

Keywords: Meet, San Rafael , Non-Clinical Study Manager II, Pharmacological Sciences, Executive , San Rafael, California

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