Company: Amoria Bond
Closing Date: 23 Jan 17
Salary (£): Negotiable
Submission Specialist – The Netherlands – 6 months Location: Utrecht area, The NetherlandsType: Contract/freelanceDuration: 6 monthsStart date: ASAPDays per week: 32 hours, 4 days per weekExciting opportunity within a global pharmaceutical company in the Utrecht area. Our client is looking for a freelance Submission Specialist with a proven track record in The Netherlands. The Submission Specialist will join a small and collaborative team. ...
Submission Specialist – The Netherlands – 6 months
Location: Utrecht area, The Netherlands
Duration: 6 months
Start date: ASAP
Days per week: 32 hours, 4 days per week
Exciting opportunity within a global pharmaceutical company in the Utrecht area. Our client is looking for a freelance Submission Specialist with a proven track record in The Netherlands.
The Submission Specialist will join a small and collaborative team. You will have the ability to work 1 or 2 days from home.
- Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals,
- Subsequent follow-up documentation, and provide updates of local processes and requirements to the Regulatory Intelligence portal.
- Taking ownership of bringing qualified sites to the status of ‘ready to enrol’ in line with the submissions
- Identify potential issues at the site during the start-up process and solve those problems independently
- Coordinating the local regulatory and EC submissions
- Providing local regulatory strategy and advice
- Review and arrange translations of relevant study documents
- Train and mentor other associates on local regulations and internal procedures.
- Additional tasks in line with business and department needs
Skills and requirements:
- Bachelor’s degree in the life science, pharmaceutical of nursing sector or equivalent research/work experience
- Relevant experience with submission within the Netherlands
- 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
- A strong and confident individual who can work independently with a proactive attitude in a fast paced work environment
Interested? Submit your CV now!
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.
Keizersgracht 270, 1016 EV Amsterdam, Nederland.
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