Country Approval Specialist - Netherlands

Do you have experience managing, preparing, reviewing and coordinating regulatory country submissions in the Netherlands? If so, this position could be for you!

We are recruiting for a Country Approval Specialist based in the Netherlands to work for a globally leading CRO.

This position is offered on a contract basis for 3 months initially, working 20 hours per week.

Responsibilities:

Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy
Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
Provide project specific local SIA services and coordination of these projects
May have contact with investigators for submission related activities
Key-contact at country level for either Ethical or Regulatory submission-related activities
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
May work with the start-up CRAsto prepare the regulatory compliance review packages, as applicable
May develop country specific Patient Information Sheet/Informed Consent form documents
May assist with grant budgets(s) and payment schedules negotiations with sites.
Support the coordination of feasibility activities, as required, in accordance with agreed timelines
Enter and maintain trial status information relating to SIA activities ontotracking databases in an accurate and timely manner
Ensure the local country study files and filing processes are prepared, set up and maintained as perWPDs or applicable client SOPsEducation:

Bachelor's degree in relevant scientific subjectSkills experience:

Knowledge of all applicable regional / national country regulatory guidelines and EC regulations
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and the ability to learn appropriate software
Good English language and grammar skills
Medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission. Where the role is marked as Outside IR35 in the advertisement this is subject to receipt of a final Status Determination Statement from the end Client and may be subject to change