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Job Details

Senior/Country Approval Specialist (Submissons) Start-Up team, Sweden-146065

Company: PPD
Location: Europe, Middle East & Africa-Sweden-Stockholm-Stoc
Reference: 146065
Closing Date: 21 Jun 18
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 development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical 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 to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com.

We have a new opening for the position of Country Approval Specialist in our Start Up (SPA - Site and Patient Access) team based at our Swedish office in Stockholm. This is a permanent, full-time position.
 
As a Country Approval Specialist, you will manage the preparation, review and coordination of country submissions and start up activities in Sweden as part of international projects.

With a life sciences degree or nursing qualification and experience of Phase II to IV trials, you will have good knowledge of EU and local regulations and ICH GCP requirements.

A background as a Clinical Research Associate with previous experience in activities associated with the start-up of clinical trials would be an advantage.

Main duties and Responsibilities include:

  • Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy
  • Provide local regulatory strategy and advice
  • Act as a key contact on a country level for all submission related activities and provide oversight for projects in start up
  • Coordinate, with internal functional departments to ensure various site start up activities are aligned with submissions activities and mutually agreed upon timelines
  • Prepare regulatory compliance review packages

Qualifications

Qualifications and experience
  • University degree in a health/science-related field will be an advantage or certified health care training or equivalent experience
  • Demonstrated experience in start-up activities (EC and CA submission management; ICF customization; Biobank submission; Radiation Committee submission)
  • Deep knowledge in EU and Swedish regulations
  • Understanding of ICH GCP
  • Strong attention to detail
  • Customer focus
  • Effective communication and interpersonal skills
  • Good organizational and time management skills
  • Ability to work in a team or independently as required
  • Fluency in Swedish and English, both written and spoken


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Apply for this job: Senior/Country Approval Specialist (Submissons) Start-Up team, Sweden-146065

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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