Regulatory & Start-Up Coordinator - Languages required

Support the delivery of activities as determined by the appropriate country, regional lead, global lead or team. May conduct specific tasks under guidance of senior staff. Responsibilities may include all or some of the activities listed at any one time.RESPONSIBILITIES

• Assist the team in the preparation, handling, distribution, filing and archiving of documentation according to the scope of work and standard operating procedures.
• Review documents for completeness, consistency and accuracy, under guidance of senior staff.
• Prepare client deliverable documents using appropriate tools and draft text for straightforward documents, under guidance of senior staff.
• Completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines and project plan with project specific information.
• Provide support for administrative tasks, e.g. meeting coordination, minute taking, travel arrangements, faxing, copying, couriers.
• Interact with internal and external clients, under guidance of senior staff.
• Perform IP release activities on small, straightforward projects or support reviews for larger projects.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Good interpersonal communication and organizational skills.
• Fluency in English and Polish or Spanish or Italian or Hungarian or Romanian Portuguese or French
• Good word processing skills and knowledge of MS Office applications.
• Good attention to detail.
• General awareness clinical trial environment and drug development process.
• Ability to work on multiple projects.
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelors degree with 0-2 years experience in an administrative environment or equivalent combination of education, training and experience.