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
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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