Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

• Prepares, reviews and coordinates local regulatory submissions (MoH, EC and additional special national local applications as applicable) in alignment with the global submission strategy.

• Coordinates with internal functional departments to ensure various site start-up activities were aligned with submission activities and mutually agreed upon timelines.

• Ensures the submission process for sites and studies are aligned to the critical path for site activation.

• Maintains contact with investigators for submission related activities;

• Serves as key-contact at country level for either Ethical or Regulatory submission-related activities.

• 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.

• May supports the coordination of feasibility activities, as required, in accordance with agreed timelines.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years)

Working Conditions and Environment:

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves