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Job Details

Senior SSU & Regulatory Specialist

Company: Syneos Health
Location: Farnborough, UK
Reference: 18005811
Closing Date: 26 Jul 18
Type: Full Time
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:

Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.

A career with Syneos Health means your everyday work improves patients’ lives around the world. 

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 looking to strengthen our Ethics and Regulatory department in the UK and are seeking an experienced individual to be based either within our EU Headquarters Farnborough, or Regionally based.

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

 

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.

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.

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Apply for this job: Senior SSU & Regulatory Specialist

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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