Regulatory Affairs Assistant
hace 2 semanas
Company Description
We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,500 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
**Job Description**:
Join our international team and support regulatory aspects of clinical research projects, streamlining communication, maintaining electronic systems and managing documents.
- Home-Based position in Colombia._
- Only CVs in English will be considered._
**You will**:
- Be the point of contact for clinical project teams and support services on regulatory matters;
- Prepare draft regulatory/ethics submission dossier;
- Be responsible for document management such as filing, processing, translation, quality control;
- Update and maintain (automated) tracking systems, working files, and schedules;
- Organize meetings, prepare agendas and minutes;
- Perform trainings of PSI clinical research staff in the departmental software.
**Qualifications**:
- College/University degree or an equivalent combination of education, training & experience;
- Life Science degree is a plus;
- Administrative work experience, preferably in an international setting is a plus;
- Prior experience in Clinical Research is a plus;
- Full working proficiency in English and Spanish;
- Ability to plan and work in a dynamic team environment;
- Communication and collaboration skills.
Additional Information
Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.
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