Job Description
Country Approval Specialist ( Submissions Specialist) – Kenya – Office based in Nairobi
PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.
As a Country Approval Specialist, You Will
PPD is currently looking for a Country Approval Specialist to join our team in Kenya ideally working form the office in Nairobi 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
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme , ensuring you reach your potential.
Apply via :
careers.ppdi.com
