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Job Details

Country Submission Specialist, Finland

Company: Syneos Health
Location:
Reference: 17005901
Closing Date: 07 Mar 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Here at Syneos Health we are currently recruiting for a Country Submission Specialist (Study Start-Up Specialist) to be based in Finland and support study start-up activities in Finland and Nordic countries.

Requirements:

17005901

Country Submission Specialist II/Senior

Finland

Home-based

Permanent contract

 

Summary

Here at Syneos Health we are currently recruiting for a Country Submission Specialist (Study Start-Up Specialist) to be based in Finland and support study start-up activities in Finland and Nordic countries.

 

Job Details:

Main responsibilities include:

  • Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission  approvals, and subsequent follow-up documentation, and provide updates of local processes and requirements to the Regulatory Intelligence portal.
  • Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
  • Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable)
  • Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.
  • Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
  • Complete review of essential documents following Essential Document Checklist QC.
  • Arrange and review translations of relevant study documents.
  • Provide regular local status updates to project lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems as required for assigned projects.
  • Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
  • Identify site issues during start-up process, resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
  • Train and mentor other associates on local regulations and internal procedures.

 

Eligibility/Qualifications/Requirements

The ideal candidate will need the following experience / skills to be considered:

  • 2-3 years’ experience working in a Study Start-up environment
  • Experience with submissions to EC/RA
  • Preferably – contract / budget negotiation experience
  • Experience with collection of essential documents, site contacts

 

Application details

If you have the required experience for this position and are eligible to work in the required location then please apply by CV.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

 

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Apply for this job: Country Submission Specialist, Finland

Contact Information:

Address:  Poland (Polska)
Ul. Nowogrodzka 68 02-014 Warsaw (Warszawa)

Poland
Website:  Visit Our Web Site

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