Submission Technical Expert
For the leading Biotech clients in Leiden I am looking for an experienced Product Development Specialist. Would you like to be part of our team to contribute to this ground-breaking development?
40 hours (mostly remote)
- Support current electronic document management and publishing tools that are used 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%
- Academic training in computer science or equivalent; Bachelors or beyond in relevant discipline
- Experience in pharmaceutical industry submission publishing or related technical skills (5-8 years)
- Proficiency in submission related FDA or EU regulations & guidelines e.g., eCTD
- Expert working knowledge of Publishing related tools, like InSight Publisher (required), InSight for Validation, Extedo EURS 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 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.
- 1 year contract (extension probable)
If you’re interested in the above description, please send me your CV. For further information, please contact Daria Petrova at +31 (0)20 20 44 502 or by email at d.petrova @panda-int.com