Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, e.g. gene therapy approvals) in alignment with global submission strategy;Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients;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;Enters and maintains trial status information relating to start up 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.