PPD clinical research services’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 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.
Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times. Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.
As a Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.
- Prepares, reviews and coordinates, 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
- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
- Provides 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 either Ethical or Regulatory submission-related activities
- Coordinates, 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
- Achieves PPD’s target cycle times for site
- 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
- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines
- Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
- Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided