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Job Details

Country Approval Specialist - Client-dedicated, Poland-127824

Company: PPD
Location: Europe, Middle East & Africa-Poland-Mazowieckie-Wa
Reference: 127824
Closing Date: 14 Jan 19
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. ...

Requirements:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

 

PPD has an exciting opportunity for a Country Approval Associate – Start-up Associate to join us onsite exclusively for one of our strategic pharmaceutical partners in Poland.  PPD works in collaboration with this partner; you will be dedicated to the client projects and sites, working within their teams, systems and processes on behalf of PPD.  


Country Approval Associate (client onsite)

/ Clinical Submission and Regulatory Specialist /


The Country Approval Associate will be responsible for obtaining Ethics and Regulatory approvals to conduct clinical studies in Poland and to ensure the activation of the sites in clinical studies.

Qualifications

Main duties and Responsibilities include but are not limited to:

  • Prepare, review and coordinate local ethics and regulatory submissions in alignment with global submission strategy;
  • Act as a key contact for the study team, on a country level, for the start-up related activities and provide oversight for projects;
  • Prepare and collect the documentation required for site’s initiation in a clinical study, in collaboration with the Clinical Research Associate;
  • Provide local regulatory strategy and advice for the conduct of clinical trials;
Qualifications:
  • Regulatory and submission experience OR 
  • CRA experience in clinical studies and good knowledge of all applicable national regulatory requirements. 
  • Fluency in English 
  • Ability to work in a team environment and independently with minimum supervision 


In return we will offer you a positive and supportive working environment within one of the most engaged teams in the industry; who are truly recognised as the cornerstone of our success. We will provide you with meaningful work and the opportunity to acquire valuable personal and professional skills.


HOW TO APPLY: Please submit your CV in English. Suitable candidates will be contacted accordingly.


PPD is an equal opportunity employer.


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Apply for this job: Country Approval Specialist - Client-dedicated, Poland-127824

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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