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Job Details

Country Approval Specialist, Madrid-148542

Company: PPD
Location: Europe, Middle East & Africa-Spain-Community of Ma
Reference: 148542
Closing Date: 17 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. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. ...

Requirements:

PPD is a leading global contract research organization providing comprehensive, integrated drug developmentlaboratory  and lifecycle management services. Our clients and partners include pharmaceuticalbiotechnologymedical device, academic and government organizations. 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 and optimize value in delivering life-changing therapies to improve health.

 

The Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

 

Essential Functions and Responsibilities:

  • Prepare, review and coordinate, under guidance, local EC submissions in alignment with global submission strategy
  • Support preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy
  • May coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures
  • alignment of submission process for sites and study are aligned to the critical path for site activation
  • Achieves PPD’s target cycle times for site
  • May have contact with investigators for submission related activities
  • May act as a key-contact at country level for either Ethical or Regulatory submission-related activities
  • Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
  • May assist in developing country specific Patient Information Sheet/Informed Consent form documents
  • May assist with grant budgets(s) and payment schedules negotiations with sites.
  • Enter and maintain trial status information relating to SIA activities onto PPD, or client (where contracted) tracking databases in an accurate and timely manner
  • Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
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Qualifications

Minimum Required Education and Experience:

  • Bachelor's degree
  • Minimum of 2 years of related experience - EC/RA Submissions 
  • Strong knowledge of national and international clinical trials legislation 

Required Knowledge, Skills and Abilities:

  • Effective oral and written communication skills
  • Excellent interpersonal skills
  • Strong attention to detail and quality of documentation
  • Good negotiation skills
  • Good computer skills and the ability to learn appropriate software
  • Good English language and grammar skills
  • Basic medical/therapeutic area and medical terminology knowledge
  • Ability to work in a team environment or independently, under direction, as required
  • Basic organizational and planning skills
  • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

 

Please note that only suitable candidates will be contacted.


Apply for this job: Country Approval Specialist, Madrid-148542

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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