Jobs Career Advice Signup
X

Send this job to a friend

X

Did you notice an error or suspect this job is scam? Tell us.

  • Posted: Feb 10, 2021
    Deadline: Not specified
    • @gmail.com
    • @yahoo.com
    • @outlook.com
  • Never pay for any CBT, test or assessment as part of any recruitment process. When in doubt, contact us

    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 more than 19,000 professionals worldwide, PPD applie...
    Read more about this company

     

    Country Approval Specialist (submissions)

    PPD is currently looking for a Country Approval Specialist to join our team in South Africa ideally working form the office in Johannesburg although flexibility may be offered to experienced candidates .

    • Prepare, review and coordinate, under guidance, local regulatory submissions ( MoH , EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy
    • Provide, under guidance 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 activitie s
    • Key-contact at country level for either Ethical or Regulatory submission-related activities
    • 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
    • May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable
    • May develop country specific Patient Information Sheet/Informed Consent form documents
    • May assist with grant budgets(s) and payment schedules negotiations with sites.
    • Support the coordination of feasibility activities, as required, in accordance with agreed timelines
    • 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

    Job Qualification
    Requirements    

    To be considered for the role of Country Approval Specialist you should have:

    • Bachelor's degree
    • 2 years related experience or equivalent combination of education, training, & experience
    • 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
    • Excellent English language 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 skill s
    • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulation

    Method of Application

    Interested and qualified? Go to PPD on careers.ppdi.com to apply

    Build your CV for free. Download in different templates.

  • Send your application

    View All Vacancies at PPD Back To Home

Subscribe to Job Alert

 

Join our happy subscribers

 
 
Send your application through

GmailGmail YahoomailYahoomail