Job Information
ThermoFisher Scientific Ctry Approval Spec in Remote, Argentina
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.
• Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.
• 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 have contact with investigators for submission related activities.
• May act as a key-contact at country level for either Ethical or Regulatory
submission-related activities.
• Works with the start-up CRA(s) to prepare the regulatory compliance review
packages, as applicable.
• Assists in developing country specific Patient Information Sheet/Informed
Consent form documents.
• Assists with grant budgets(s) and payment schedules negotiations with sites.
• Enters and maintains trial status information relating to SIA activities onto PPD,
or client (where contracted) 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 0 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.