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Job Details

Senior SSU & Regulatory Specialist (Bulgaria)

Company: Syneos Health
Location: Bulgaria
Reference: 18001099
Closing Date: 12 Feb 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

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.

Requirements:

As a member of our Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study. This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard.

We are currently looking to strengthen our Ethics and Regulatory department in Bulgaria and are seeking an experienced SSU & Regulatory Specialist.

A brief summary of duties you will be involved in as a Site Start up Specialist:


• Reviewing essential document packages for site activation
• Preparation and submitting of Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required
• Reviewing Informed Consent Forms
 

Qualifications

 

To succeed in this role you will need the following skills/experience:

• Previous experience in clinical research including submissions experience

• Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive as well as any applicable rules applicable locally.


What happens next:

If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.

Apply for this job: Senior SSU & Regulatory Specialist (Bulgaria)

Contact Information:

Address:  INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
1126
Hungary
Tel:  +36 1 489 48 56
Website:  Visit Our Web Site

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