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Study Start-up/Regulatory Submissions Coordinator
This vacancy has now expired. Please see similar roles below...
Proclinical is working with a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas.
This company's clinical activities are growing rapidly, and they are currently seeking a full-time, home-based Regulatory Submissions Coordinator to join their Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Job Responsibilities:
- Prepare, review, and file clinical trial applications to domestic and regional regulatory agencies;
- Ensure submissions comply with applicable regulations and guidance documents;
- Provide support with local site contract & budget negotiations
- Advise sponsors on changing regulations and compliance requirements; and
- Track submissions and ensure timely filing of documents.
Skills and Requirements:
- Bachelor's degree in life sciences;
- Experience with site contract & budget negotiations preferred, but not required
- Excellent organization and communication skills;
- Knowledge of Microsoft® Office; and
- Hands-on experience preparing, reviewing, and submitting regulatory documentation;
- At least one year of work experience as a Regulatory Submissions Coordinator;
- Fluency in English and local language.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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