Country Approval Specialist (submissions) at PPD

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