What are the responsibilities and job description for the eCTD Publisher position at AMISEQ?
Job Description
Roles and Responsibilities:
• Preparation of the assigned eCTD submissions in collaboration with the EU Regulatory Affairs and Regulatory Operation counterparts in the US
• Responsible for the control of Client document standards are adhered
• Ensuring on-time delivery of high quality, compliant and valid eCTD submissions for the different countries
• Manage the dispatch of the submissions via diverse electronic submission channels (e.g. CESP, EMA Gateway)
• Knowledge of the Health Authority guidelines concerning the electronic submissions and ensuring their proper application
• Participating in special projects (e.g. developing processes within the team’s area of responsibility)
Personal Skills and Professional Experience:
• Bachelor’s degree in natural science or PTA education
• 2-3 years of experience in the regulatory environment
• Hands-on experience with the eCTD compilation and publishing
• Proven ability to work with a document management system and an electronic publishing tool
• Used to work towards deadlines and able to prioritize
• Collaborative and service-oriented mindset
• Strong working knowledge of Microsoft Office
• Written and verbal communication skills in English, German is a plus
Salary : $40 - $50
