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    Regulatory Operations Specialist II - Amman, الأردن - Ora, Inc

    Ora, Inc
    Ora, Inc Amman, الأردن

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    • About the job

      POSITION TITLE: Regulatory Operations Specialist II

      DEPARTMENT: Ora Europe

      LOCATION: UK or Europe

      Ora Values the Daily Practice of...

      Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

      The Role:

      The Regulatory Operations Specialist is responsible for assisting the Regulatory submissions team in QC, coordination of document preparation, management, and submissions within (and around) Europe. This is a team and individual contributor role, reporting to the Manager of Regulatory. This position will work collaboratively with regulatory, country CRA and project team. This position requires a strong technical background, a high degree of enthusiasm, enjoyment of working in a fast-paced environment, being self-motivated, and being able to use critical reasoning to solve problems and make decisions.

      What You'll Do:

      Under the supervision of the European Regulatory Manager:
    • Performs the role of a Regulatory Lead for studies within the European region during study start-up until study close out
    • Oversees and performs quality control checks on clinical and regulatory documents, including Patient Information Sheet (PIS)/Informed Consent Form (ICF)
    • Responsible for and contributes to preparation and submission of documents to regulatory authorities and ethics committees, primarily within the Clinical Trial Information System (CTIS)
    • Performs quality control checks on study documents that are received from the sponsor and/or prepared by country CRAs to ensure all submission documents meet Ora's submission standards
    • Oversees, coordinates and contributes to development of country adapted study documents and ensuring documents are sponsor approved prior to finalization
    • Contributes to the review and revision of standard operating procedures (SOPs), templates, and forms
    • Performs data entry for tracking of regulatory submission activities
    • Updates tracking logs, databases, and ensure filing of country adapted and sponsor approved study documents are filed in collaborative workspace
    • Prepares the clinical trial application within CTIS for Part I with supervision; in compliance with forecasted timelines
    • Escalates potential issues identified to impact forecasted timelines quickly
    • May be required to provide regulatory support in other regions
    • Keep up to date with current regulations, guidelines and changes in the industry
    • Collaboration with Global Regulatory team and wider stakeholders
    • Responsibilities may differ slightly from the above based on specific needs of the business.
    • Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
    • What We Look For:
    • Experience needed for the Role:
      • Bachelor's degree in applied or life science/healthcare or equivalent
      • 3 years of medical, regulatory, or clinical experience or equivalent training and work experience, including coursework.
      • Experience with clinical research including overseeing or making submission in a country or region
      • Understanding of Clinical Trial Information System (CTIS) and EU CTR
    • Additional Skills & Attributes:
      • Competency in Microsoft Office applications, especially Word
      • Ability to work well in a team environment, have a strong commitment to the accomplishment of tasks, can follow procedures, and has the initiative to identify opportunities for improvements and the inter-personal skills to promote and accomplish constructive solutions to problems.
      • Ability to work in a fast-paced environment
      • Attention to detail with emphasis on accuracy and quality
      • Ability to prioritize work to balance multiple projects and deadlines
      • Excellent verbal and written communication skills
      • Experience updating and reviewing PIS/ICF templates
      • Familiarity with the clinical trial process and regulatory submissions regulations and guidelines within Europe
      • Familiarity with ICH-GCP standards
    • Competencies and Personal Traits:
      • Attention to Detail: Ability to analyze data to drive successful solutions to complex problems.
      • Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy.
      • Intellectual Curiosity: Willingness and desire to learn new things and dig deeper than the surface.
      • Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again.
      • Organization and Goal Setting: Ability to set goals, develop structure and maintain a focused approach to critical path work.
      • Resolve Conflicts: Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood.
      • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.
    • What We Offer:
    • Financial: Competitive salaries along with a structured pension plan.
    • Well-Being: Offering private medical insurance healthcare beginning day 1 provided by Vitality and SimplyHealth.
    • Company Paid Life & Disability Insurance: Offering peace of mind through Canada Life to help you and your family feel secure.
    • PTO: 25 days of annual leave + Birthday PTO + bank holidays.
    • Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
    • Career Development Opportunities: Continued opportunities to grow and develop your career journey.
    • Global Team: Opportunities to work with colleagues across the globe.
    • Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.
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