• Regulatory Specialist - Global Regulatory Archivist

    Location US-DE-Newark
    Job ID
    2018-8714
    # Positions
    1
    Category
    Regulatory
    Type
    Full Time
    Visa Sponsorship
    No
    Company Vehicle
    No
    Working from Home Office
    No
    Relocation Eligible
    Yes
    Lifting required
    Yes
  • Company Overview

    FMC Corporation is a leading specialty company focused on agricultural technologies. FMC provides innovative and cost-effective solutions to enhance crop yield and quality by controlling a broad spectrum of insects, weeds and disease, as well as in non-agricultural markets for pest control.
     
    FMC is a globally diverse organization that offers its employees exciting opportunities to work on challenging projects that are important to the achievement of our strategic objectives. Your education and professional experience are valued and put to use from day one. Your success at completing key initiatives can result in a varied, progressive and fulfilling career with FMC.
     
    With a corporate culture of innovation, integrity, responsibility and customer intimacy, we foster “The Right Chemistry” in everything we do. We are looking for people to join us in creating, developing, and improving our products, our processes, and our markets.  If you are ready to make a difference every day, FMC is ready to talk to you.

    Overview

    The Global Regulatory Archivist reports to the Global Regulatory Program Manager, working closely with the regulatory scientists and registration managers to ensure scientific content needed to support the registration of FMC products globally is properly archived per US EPA Good Laboratory Practice Standards (GLP) and available in the electronic regulatory database.

    Responsibilities

    Responsibilities include but are not limited to the following:

     

    • Makes safety a key consideration of all activities. Works in a safe manner and support a safe working environment for both self and others. Complies with all FMC safety and security policies.
    • Manages the GLP study record paper archives according to US EPA Good Laboratory Practice Standards, FMC Standard Operating Procedures and procedures outlining the responsibilities of the archivist.
    • Maintains paper and electronic databases to ensure international regulatory requirements and business needs are met.
    • Able to read technical documents and data packages to extract relevant information needed for electronic archiving.
    • Knowledgeable of electronic document archives, facilitates data extraction for scientists and regulatory managers.
    • Independently works with FMC scientists and outside laboratories to resolve issues related to the quality and completeness of paper GLP study data packages submitted to the archive.
    • Writes and maintains the standard operating procedures for the archive.
    • Demonstrates continuous pursuit of knowledge in archiving best practices.
    • Attends assigned trainings.
    • Participates in GLP regulatory authority inspections.

    Required Education

    A Bachelor’s degree involving library sciences, a scientific discipline or equivalent experience

    Qualifications

    • Fundamental scientific understanding of such things as chemical nomenclature.
    • Strong communication and interpersonal skills, ability to work with people of other cultures
    • Strong record-keeping, categorizing, and organizational skills
    • Understanding of GLPs and requirements for maintaining records per the standards
    • Technical writing expertise (e.g., Word, Excel, scientific writing experience)
    • Strong computer skills to be able to manipulate databases, to manage spreadsheets, and to interface with SharePoint sites
    • Experience in learning and continuously developing

    EEO Statement

    At FMC, diversity and inclusion are in our DNA. We are proud to be an Equal Opportunity Employer with a commitment to creating an inclusive workplace where all employees can thrive – regardless of race, gender, sex, pregnancy, gender identity and/or expression, sexual orientation, national origin or ancestry, citizenship status, color, age, religion or religious creed, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other basis protected by federal, state or local law. FMC also supports employee participation in company employee resource groups that celebrate the diverse backgrounds of our workforce by providing communities for employees to connect with each other and raise awareness throughout FMC.

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