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Job Details

Senior SSU & Regulatory Specialist

Company: INC Research
Location: Moscow
Reference: 17003771
Closing Date: 14 Dec 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life.

Requirements:

We are always looking to strengthen our Ethics and Regulatory department in Russia and would welcome applications from experienced SSU & Regulatory backgrounds whom would like to be based in our office in Moscow.

 


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.

 


Core responsibilities:

A brief summary of duties you will be involved in as a Senior 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.

 

Why choose us:

It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.

We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.

“INC Research has been ranked as “Top CRO to work with” among large global CROs in the biannual CenterWatch Global Investigative Site Relationship Survey. INC is the only CRO to rank consistently among the top three CROs in all seven CenterWatch site relationship surveys conducted since 2007”

 

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

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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