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Herakles Pharma

EC/CA submission specialist / Clinical Regulatory Specialist

Functiegroep: Clinical Operations
Locatie:Maarsbergen
Procedure: W&S
Vacature ID:#716
Publicatiedatum:20-05-2019

EC/CA submission specialist / Clinical Regulatory Specialist

De organisatie

For one of our CRO clients in the Utrecht region we are looking for a EC/CA submission specialist / Clinical Regulatory Specialist.

Job title with the same responsibilities can be: Start-Up Specialist, Clinical SU specialist or Country Approval Specialist

De functie

The EC/CA submission specialist / Clinical Regulatory Specialist will manage the preparation, review and coordination of Ethics Committee and Regulatory submission in The Netherlands and will coordinate all activities to get investigation sites ready to enroll patients in our clinical trials.

Responsibilities for the function as EC/CA submission specialist / Clinical Regulatory Specialist:

  • Preparation, reviewing and coordinating local ethics and regulatory submissions in alignment with global submission strategy;
  • Providing local regulatory strategy and advice;
  • Acting as a key contact on a country level for all submission related activities and provide oversight for projects;
  • Taking ownership of bringing qualified sites to the status of ‘ready to enrol’;
  • Contacts sites to resolve issues and determines completeness and readiness of site for IP Approval;
  • Maintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided;
  • Ensures the study files and filing processes are followed for the documents sent to file as per company WPDs or applicable client SOPs;
  • Additional tasks in line with business and department needs.

Het profiel

Qualifications for the function as EC/CA submission specialist / Clinical Regulatory Specialist:

  • Bachelor’s degree in a life science subject;
  • Regulatory and submission experience and a good knowledge of applicable local requirements;
  • Basic medical/therapeutic area and medical terminology knowledge;
  • Excellent communication and organisational skills and a self-motivated, flexible and professional attitude. The ability to handle multiple tasks effectively, often within strict deadlines is essential;
  • Dutch and English language skills.

Het aanbod

competitive salary

Inlichtingen bij

More information about this position as a EC/CA submission specialist / Clinical Regulatory Specialist? Please contact Leonie Koomen at leonie@heraklespharma.nl or 06-10518323.