Regulatory and Start up Specialist
Under direction of line manager, support the delivery of activities as determined by the appropriate country, regional lead or global lead. May conduct specific tasks under guidance of senior staff. Responsibilities may include all or some of the activities listed at any one time.
- 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 may draft text for straightforward documents, under guidance of senior staff.
- Assist with completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines and project plans 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.
- May 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.
- 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.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor degree, preferably with Legal background
- At least 1 years’ experience in regulatory and start up activities
- Fluent in English
- Excellent interpersonal skills
- Hibrid set up: 3 days at the office and 2 days from home
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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