About PPD
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!
Diversity Statement
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.
The Role:
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.
Responsibilities:
- 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