Ctry Approval Spec
Work Schedule Standard (Mon-Fri) 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. 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 2+ 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
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