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Job Details

Clinical Submission Specialist Belgium-145271

Company: PPD
Location: Europe, Middle East & Africa-Belgium-Brussels-Capi
Reference: 145271
Closing Date: 19 Jun 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD has an exciting opportunity for a Country Approval Specialist (Submission Specialist) to join our Site and Patient Access team in Brussels. ...

Requirements:

PPD has an exciting opportunity for a Country Approval Specialist (Submission Specialist) to join our Site and Patient Access team in Brussels. The Country Approval Specialist will manage the preparation, review and coordination of Ethics Committee and Regulatory submission in Belgium and will coordinate all activities to get investigational sites ready to enroll patients in our clinical trials

 

This is a great opportunity to grow your career within a Start up function within an award winning Global CRO!

 

Duties include:

  • 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 enroll’
  • Draft, review and track contracts, utilizing your legal and commercial acumen.
  • Work with global project teams to provide them with contract and legal support of a high caliber to meet tight deadlines.
  • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
  • Additional tasks in line with business and department needs

Qualifications

Qualifications:

·        

  • 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.
  • French, Flemish and English language skills
PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a world-leading company amongst Global CROs and consistently has won accolades for our industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional talent to join our company.

 

Submit your CV before the 4th June to be eligible for a €5000 joining bonus should you be successfully hired by PPD

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Apply for this job: Clinical Submission Specialist Belgium-145271

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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