Covance

  • Medical Regulatory Writing Associate I

    Job Location(s) US-WI-Madison
    Job Number
    2018-20536
    Job Category
    Scientific Entry Level
    Position Type
    Full-Time
  • Job Overview

    Medical Regulatory Writing Associate I

     

    Responsibilities

     

    The purpose of the position is to work with the other members of medical writing to assist sponsors and the internal operating groups of Covance to provide nonclinical sections of regulatory filing documents in support of new drug applications.

     

    • Prepare tables of nonclinical information pharmacology, pharmacokinetics, toxicology for inclusion in Investigator Brochure, Tabulated and Written Summaries and Background Packages supporting requests for agency interactions (eg, Pre-IND meetings, special protocol assessments).
    • Provide format and editorial reviews and updates of written summary documents or any other document prepared by another writer or as part of a comprehensive submission regardless of the source of the document (eg, Pre-IND background package).
    • Acquire a basic understanding of the nonclinical subject matter and applicable guidance and regulations; and works with manager to identify areas for continued education.
    • Works with staff from other groups in Medical Writing and groups external to Medical Writing to ensure preparation of quality documents on time and within budget.
    • Demonstrate an understanding of how to work with staff (eg, project managers) in other group to obtain study reports, co-ordinate timelines (eg, regulatory publishing and submissions)
    • Attend meetings within Covance and with the Sponsor, as applicable
    • Develop and maintain optimal department processes and implements effective project‑specific strategies.
    • Develop processes and procedure to ensure best working practices are maintained.
    • Assist in maintaining templates and tracking documents.
    • Interact with clients around client deliverables and review cycles.
    • Represent the department in inter-department and working groups.
    • Represent the company at meetings with clients, as applicable.
    • Identify ways to improve the efficiency and quality of work processes.
    • Cross-trained and provide assistance to other departments (eg, Quality Control) on an ad hoc basis.
    • Perform other duties as assigned by the Manager (i.e., Sr. Director).

    Education/Qualifications

    • BS degree in related science/regulatory affairs.
    • Proven ability to communicate at multiple levels of management, senior scientists, and technical support teams.
    • Outstanding communicator (oral and written).
    • High level of attention to detail and specifics.
    • Ability to understand and perform basic mathematical computations.
    • Rudimentary understanding of statistics.
    • Well developed leadership skills.
    • Outstanding customer service and focus on client needs.

    Experience

    • 1-2 years of experience working in a nonclinical regulatory environment and completing regulatory documents.
    • Knowledge of GLP regulations.
    • Knowledge of US FDA regulations and drug development guidance documents.

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