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Job Details

SSU & Regulatory Specialist - Belgium

Company: INC Research
Reference: 17003516
Closing Date: 10 Sep 17
Type: Permanent
Salary (£): Negotiable

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.


At INC Research/inventiv Health we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.

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 Belgium and are seeking a Study Start Up and Regulatory Specialist to be based from our Zaventem office.

Due to continued growth at INC Research this new exciting blended position will encompass both the Site Start up and Regulatory activities as well as Site Contracts Activities.

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

Independently administers and negotiates site contracts that support projects within Clinical Operations in accordance with sponsor and Company requirement
Facilitates contract management functions with internal and external legal, finance, and clinical operations departments
Reviews essential document packages for site activation
Prepares and submits local regulatory authorities or hospital approval submissions as required
Reviewing Informed Consent Forms
Serves as communication liaison between site contracts staff and internal and external customers


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

BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience
Moderate study start up and regulatory experience
Experience in a contract research organization, pharmaceutical, or biotechnology company preferred
Knowledge of and understanding of the overall drug development process. Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive
Demonstrated clinical development and clinical research knowledge.

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.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Apply for this job: SSU & Regulatory Specialist - Belgium

Contact Information:

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

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