Sr Ctry Approval Spec

Work Schedule

Environmental Conditions

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:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to5 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