Regulatory Operations Specialist II
Posted on :
06-07-2024
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1 Vacancy
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Job Description
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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.
Employment Type
Full Time
Company Industry
Department / Functional Area
Key Skills
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