Ora, Inc Company wants to hire Regulatory Operations Specialist II in Kuwait تعلن شركة Ora, Inc في توظيف أخصائي العمليات التنظيمية II في الكويت

Kuwait Jobs Today Ora, Inc Company announces new job opportunities. Are you
looking for job opportunities in Kuwait? Ora, Inc Company announces the
opening of recruitment for many jobs in various specializations in Kuwaiton
today's date. These opportunities are available to all nationalities. Learn
about the available jobs and how to apply through the following advertisement.
Required jobs in Ora, Inc company and their details:
Regulatory Operations Specialist II
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.
How to apply for jobs
To apply for the aforementioned jobs, you can follow these steps:
To go to the application page. (
Job opportunities for Ora, Inc Company
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Enter the required information in the pop-up screens.
Click Review to review the form.
Source and additional details
Job source: The official website of the company
Posted Date: ‎10-‎2-‎2024 (Please check the date before applying).
Required Nationalities: All nationalities.