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Job Details

Regulatory Submission Specialist - Bulgaria

Company: Skills Alliance
Location: Sofia city
Reference: RWBul1302
Closing Date: 07 Mar 17
Type: Permanent
Salary (£): 30,000 - 40,000
Benefits:

Job Summary:

Radek Weichert at Skills Alliance is recruiting for a Regulatory Associate / Study Start-up Associate / SSU Specialist with focus on submissions in Bulgaria and South East /...

Requirements:


Radek Weichert at Skills Alliance is recruiting for a Regulatory Associate / Study Start-up Associate / SSU Specialist with focus on submissions in Bulgaria and South East Europe and Turkey to join a medium CRO, working home or office based in Bulgaria / Sofia on a permanent basis.

You'll be accountable for:
Quality deliverables in Bulgaria for site start-up.
Forecasting submission/approval timelines and ensuring they are adhered to.
Essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines
Progressing and tracking site recruitment and approvals according to study timelines
Ensuring accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to maintenance for filing in TMF
Collecting information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees and other local bodies.
Setting up and maintaining a country folder with country Ethics Committees and local authority addresses and requirements
Documenting QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client
Coordinating submissions in South Eastern Europe and Turkey.

You'll need this to be considered:
BSc, MSc or equivalent
Prior experience in Clinical Research with experience in start-up activities
Prior experience using computerized information systems preferred
Ability to read, write, and speak in English and Bulgarian.
Clinical trials support or pharmaceutical industry experience preferred
Knowledge of ICH and local regulatory authority drug research and development regulations preferred

Location: Bulgaria
Salary and benefits: Very competitive
Please contact Radek Weichert with the latest version of your CV on: Radek.Weichert @ skillsalliance.com or call for confidential discussion on: +44 20 7220 6238

Key Words
Senior CRA / SCRA / Senior Clinical Research Associate / Lead CRA / LCRA / Monitoring /Monitor / Clinical Trial / Drug Trial / Trial Sites / Clinical / CRA 1 /CRA 2 / ICH-GCP / Clinical Research / Clinical Trials / Study Start-Up / Start-Up / Study Start Up / SSU / Clinical Study Start-Up/ Clinical Study Start Up / Clinical Study Startup / Regulatory Affairs / Regulatory Documents / ICH-GCP /Senior CRA / SCRA / Senior Clinical Research Associate / Lead CRA / LCRA / Monitoring / Monitor / Clinical Trial / Drug Trial / Trial Sites Sofia / Bulgaria /

Apply for this job: Regulatory Submission Specialist - Bulgaria

Contact Information:

Address:  Head Office
10 Aldersgate Street, London
EC1A 4HJ
England
Tel:  +44 20 7220 6200
Fax:  +44 870 831 1705
Website:  Visit Our Web Site

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