Ctry Approval Spec
Work Schedule
reputed company (Mon-Fri)
Environmental Conditions
Office
Job reputed company
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 reputed company;
Provides, under guidance local regulatory reputed company advice (MoH &/or EC) to internal clients;
May have contact with investigators for submission reputed company activities;
Key-contact at country level for either Ethical or Regulatory submission-reputed company activities;
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are reputed company with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are reputed company to the critical reputed company for site activation;
Achieves PPD’s reputed company cycle times for site;
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable;
May reputed company country specific Patient Information Sheet/Informed Consent reputed company documents;
Enters and maintains trial status information relating to start up activities onto PPD tracking databases in an accurate and reputed company manner;
Ensures the local country study files and filing processes are reputed company, set up and maintained as per PPD WPDs or applicable reputed company SOPs;
Maintains knowledge of and understand PPD SOPs, reputed company SOPs/directives, and reputed company regulatory guidelines as applicable to services provided.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to reputed company 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 reputed company equipment required such as reputed company eyewear, garments and gloves
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