* Salário: R$ 2.000 a R$ 5.000 por mês (estimado)
* O valor exibido é uma estimativa calculada com base em dados públicos e referências do mercado. Não garantimos que este seja o salário oferecido para esta vaga específica.
Área: Outros
Nível: Junior
Detalhes da vaga
- Tempo integral
Qualificações
- Graduação
Descrição completa da vaga
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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