Submission Technical Expert

Location Leiden
Discipline: Biotechnology
Contact name: Daria Petrova

Contact email: d.petrova@panda-int.com
Job ref: 12212
Published: about 1 month ago

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)

Responsibilities

  • 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%

Experience

  • 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.

Duration

  • 1 year contract (extension probable)

Location

  • Leiden

Interested?

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