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Job Details

Regulatory and Site Services Specialist - Sweden

Company: Chiltern
Location: Home based - Sweden
Reference: NC900065
Closing Date: 08 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Our successful and dynamic team in Sweden are currently looking to expand. Are you searching for an exciting new role? Do you have experience in start-up, ethics committee applications and regulatory affairs in the Nordics? Then this is a fantastic opportunity for you!

Requirements:

Job Background

 

Duties & Responsibilities

Department specialist in regulatory and project start-up & maintenance activities for the Nordics.  Responsible for executing the majority of regulatory and start-up & maintenance activities on projects, within the project timelines and in line with the study start up portion of the budget.

This role will have responsibility for CA and EC submissions locally in Sweden and another Nordic country based on the applicant´s previous experience.

 

1. Responsibility for regulatory and ethics submissions subject to resource needs

2. Development of Informed Consent Forms, labels and other patient facing material in accordance with country-specific requirements.

3. Coordinate and/or perform the preparation, quality control review, and submission of CTA packages including initial submission, amendments and End of Trial Declarations as well as non-substantial notifications, status reports etc. to the CA and IRB/IECs and to any other country specific authority/body in assigned countries (except FDA).

4. Prepare and respond to Competent Authority (CA) and Ethics Committee (EC)/Institutional review Boards (IRB) and to any other country-specific authority/body after Regulatory Project Lead/Manager approval.

5. Develop and produce metrics and status reports to support the needs of Project Managers, line management, and other senior-level department colleagues.

6. Facilitate/participate in training programs and department meetings.

 

Requirements

The successful candidate will be well experienced with CA and EC submission in Sweden/Nordics and should have profound knowledge on Swedish/Nordic laws and regulations concerning clinical research.

 

We are looking for someone who can work independently given that this is a home-based position.

Relevant experience in study start up and regulatory activities within Clinical Research, skills to successfully perform the key responsibilities of the job

 

Company information

Chiltern is Europe’s largest privately owned full service (Phase I-IV) Clinical Research Organization, with 4300 employees and offices throughout Europe, both Eastern and Western, North and South America and Asia. We have worked in virtually every therapeutic area for all the major pharmaceutical companies and very many of the smaller ones.

 

Additional information:

To apply for this position please email your CV and covering letter to nicky.cooke@chiltern.com - nicky.cooke@chiltern.com

 

For more information about Chiltern International, please visit our web site at www.chiltern.com

 

Please note that if your experience does not mirror that of our requirements for this role you may not receive a response

 

Candidates must be eligible to work in Sweden

 

 

NO AGENCY APPLICATIONS WILL BE CONSIDERED

 

 

 

 

 

Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

 

 

 

Salary

Competitive salary and benefits

Position Type

Permanent
Full Time

Contact

Email Nicky Cooke - Nicky.Cooke@chiltern.com
+44 (0) 1753 216729

 

Apply for this job: Regulatory and Site Services Specialist - Sweden

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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