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Job Details

Submissions Specialist - Work from home - Netherlands

Company: Amoria Bond
Location: Netherlands
Reference: J5868445
Closing Date: 27 Dec 16
Type: Contract
Salary (£): 80,000 - 100,000
Benefits:

Job Summary:

Clinical Submission Specialist, 6 months, Netherlands Submission specialist, freelance, regulations, GCP, ICH, IRB, EC, ASAP, CTA, Clinical trials, Submissions, Review, Translations, Patient info, CRA, Manager, Freelance, Interim, ZZP, Holland, Netherlands, UtrechtA busy and thriving Global Pharmaceutical company in the Netherlands needs a Clinical Submission Specialist with a proven track record to join their team asap!Responsibilities will include:- Conduct research and maintain proficien ...

Requirements:

Clinical Submission Specialist, 6 months, Netherlands

Submission specialist, freelance, regulations, GCP, ICH, IRB, EC, ASAP, CTA, Clinical trials, Submissions, Review, Translations, Patient info, CRA, Manager, Freelance, Interim, ZZP, Holland, Netherlands, Utrecht

A busy and thriving Global Pharmaceutical company in the Netherlands needs a Clinical Submission Specialist with a proven track record to join their team asap!

Responsibilities will include:
- Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals
- Taking ownership of bringing qualified sites to the status of ‘ready to enrol’ in line with the submissions
- Translations for patient info documentation, reviews, etc.
- Identify potential issues at the site during the start-up process and solve those problems independently
- Coordinating the local regulatory and EC submissions
- Review and arrange translations of relevant study documents
- Additional tasks in line with business and department needs
- Providing local regulatory strategy and advice

Skills and requirements:
- Relevant experience with submission within the Netherlands
- Degree-educated or equivalent
- A good communicator who has the ability to effectively interact with project teams
- Must be familiar with GCP/ICH guidelines and good knowledge of relevant regulations
- Fluent in both spoken and written Dutch and English

You will be proactive, an independent worker and show flexibility.

Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.

Apply for this job: Submissions Specialist - Work from home - Netherlands

Contact Information:

Address:  Head Office
Keizersgracht 270, 1016 EV Amsterdam, Nederland.

Netherlands
Tel:  +31 (0) 20 80 80 888
Website:  Visit Our Web Site

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