Job Description

Position Overview

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 mentorship, local regulatory strategy advice (MoH &/or EC) to internal clients. Provides project specific local SSU 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.

Responsibilities

• 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 the need arises, in accordance with agreed timelines.
• Enters and maintains trial status information relating to SIA activities onto PPD supervising 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 understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Employment Type

• Full time

Work Schedule

• Standard (Mon-Fri)

Environmental Conditions

• Office

Salary

• [Salary information not provided]

Location Type

• [Location Type information not provided]