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Job Details

Regulatory Site Activation Manager

Company: Syneos Health
Location: Europe - UK Regional
Reference: 17005950
Closing Date: 14 Mar 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:

At Syneos 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 are looking to strengthen our Ethics and Regulatory department within Europe and are seeking a Regulatory Site Activation Manager to be based in Europe.

A brief summary of duties you will be involved in as a Regulatory Site Activation Manager:
 

Acting as a key point of contact with the sponsor and internal team regarding all Regulatory activities for the assigned study 

Overseeing all associates assigned to work on the regulatory, ethics and essential document portion of the study

Assuming responsibility on deliverables at the project level 

The planning, coordination and oversight of all processes involved in gaining approvals required in each country for a clinical trial to commence. This will include competent authority approvals, ethics committee approvals, import license approvals, radiation approval, tissue/biological sample export and any other local approvals required in a given country. 

Dealing with multiple countries and studies at any given time

 

Qualifications

 

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

Degree educated or equivalent in a science or healthcare field 

Direct experience making CA submissions across multiple countries 

Excellent understanding and experience in Regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release requirements in multiple European countries 



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: Regulatory Site Activation Manager

Contact Information:

Address:  European Head Office
River View, The Meadows Business Park, Station Approach, Blackwater, Surrey
GU17 9AB
England
Tel:  +44 (0) 1189 335 300
Website:  Visit Our Web Site

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