Powrót do wyników wyszukiwania Dodane 5 października 2016

Country Approval Specialist - Germany-129381 - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
  • Miejscowośćinne
  • AdresGermany,
Dodaj do:



Country Approval Specialist - Germany-129381

Nr ref.: /JOBS.pl

  • PPD now has an exciting new opportunity in Germany for a Country Approval Specialist to join our Site Intelligence & Activation team.

    This is an office based, full-time position, located in either Munich or Karlsruhe, Germany.

    In this role you will:

    - Prepare, review and coordinate, local regulatory submissions (MoH, EC, additional special national local applications if applicable. in alignment with global submission strategy
    - Provide local regulatory strategy advice (MoH &/or EC) to internal clients
    - Provide project specific local SIA services and coordination of these projects
    - May have contact with investigators for submission related activities
    - Key-contact at country level for Ethical and Regulatory submission-related activities
    - Coordinate 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
    - Prepare the regulatory compliance review packages, as applicable
    - Develop 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 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
    - Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

    QualificationsBachelor's degree
    - 2 years related experience preferred, or equivalent combination of education, training, & experience

    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


Aplikuj teraz

Ogłoszenie pochodzi z serwisu Jobs.pl.

najnowsze ogłoszenia w tej kategorii

Proszę czekać - ładowanie treści...