Country Approval Specialist

Highly Competitive
  1. Permanent
  2. Clinical Scientist
  3. Belgium
Brussels
Posting date: 12 Jun 2019
CR.GM.23831_1560356137

ProClinical is advertising a vacancy for a Country Approval Specialist Submissions position with an international contract research organisation. The company, which provides drug discovery, lifecycle management, and laboratory services, is seeking for a driven and talented individual to join their company in their Brussels office. This is an exciting opportunity to work with a company that provides innovative ideas behind multiple pharmaceutical sectors.

Job Responsibilities:

  • Preparing, reviewing, and coordinating 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.
  • Providing local regulatory strategy advice (MoH &/or EC) to internal clients.
  • Providing 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.
  • Coordinating with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines.
  • Ensuring alignment of submission process for sites and study are aligned to the critical path for site activation.
  • Achieving the company's target cycle times for site.
  • Working with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
  • Developing country specific Patient Information Sheet/Informed Consent form documents.
  • Assisting with grant budgets(s) and payment schedules negotiations with sites.
  • Supporting the coordination of feasibility activities in accordance with agreed timelines.
  • Entering and maintaining trial status information relating to SIA activities onto company tracking databases in an accurate and timely manner.
  • Ensuring the local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs.
  • Maintaining knowledge of and understanding SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Skills and Requirements:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years') or equivalent combination of education, training, & experience.
  • Good English, Dutch and French language and grammar skills.
  • Basic medical/therapeutic area and medical terminology knowledge.
  • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Gilles Maricaux at +44 203 854 0104 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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