For one of our clients in Leiden, we are urgently looking for a Submission Technical Expert for an initial project of 9 months.
- Do you have academic training in computer science or equivalent?
- Do you have experience in pharmaceutical industry submission publishing or related?
- Are you proficient in submission related FDA or EU regulations & guidelines?
- Do you have knowledge of Publishing related tools, like InSight Publisher, ISI Publisher, InSight for Validation, Extedo Global Validator, Lorenz eValidator, InSight for Viewing, ISI Toolbox etc?
Then you are the ideal candidate for this position so please apply today!
This position is responsible for supporting the tools used for electronic publishing of regulatory submissions by RSMO Publishing and Local Operating Companies, working independently with minimal supervision.
The incumbent will support the training of junior specialists and oversee the work of others from an operational perspective to ensure the quality of output. The incumbent will be proficient in eCTD lifecycle standards and requirements.
The incumbent may also be assigned various independent or team-based projects primarily focused on process improvement initiatives or the testing and implementation of new submission related technologies.
The incumbent is expected to identify opportunities to streamline processes or enhance the overall quality of output.
• Support current electronic document management and publishing tools to assemble and publish dossiers according to regulatory requirements for paper and electronic submissions. 40%
• Troubleshoot and provide first-line support to RSMO Publishing. Serve as a helpdesk for inquiries regarding regulatory requirements and guidelines. 40%
• Monitor electronic publishing requirements and determine the scope for tool maintenance/development. 5%
• Assess processes to ensure that organizational responsibilities are met for quality, delivery, and effectiveness. 5%
• Develop opportunities for business process improvement. 5%
• Assist in technical training of team members & provide ongoing guidance to ensure internal standards/procedures are adhered to. 5%
KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:
• Academic training in computer science or equivalent; Bachelors or beyond in relevant discipline
• Must have enough experience in pharmaceutical industry submission publishing or related technical skills to be able to operate independently in this role
• Proficiency in submission related FDA or EU regulations & guidelines e.g., eCTD
• Expert working knowledge of Publishing related tools, like InSight Publisher, ISI Publisher, InSight for Validation, Extedo Global Validator, Lorenz eValidator, InSight for Viewing, ISI Toolbox etc.
• Strong communication skills: oral, written and effective listening
• Sound understanding of information management concepts and tools needed to support the business area.
• Practical understanding of evolving technologies in support of business area.
• Use various technical skills and experience to solve publishing/document processing issues
• Can demonstrate a solid command of the technical tools needed to perform job duties.