Regulatory & Start Up Specialist 1
hace 3 semanas
**RSU Specialist for External Commerce (ComEx)**
**Essential Functions**
- Responsible for importations and exportation activities in Colombia for our FSP model
- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents.
- May have direct contact with sponsors on specific initiatives.
**Requirements**:
- Clinical research experience. Equivalent combination of education, training and experience.
- At least 1 year experience related to international trade, import and export processes in pharmaceutical industry
- Advanced English level
- Good communicational and interpersonal skills
- Good organizational skills
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