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Herakles Pharma

Submission Technical Expert

Locatie:Leiden
Procedure: Detachering
Vacature ID:#730
Publicatiedatum:08-02-2019

Submission Technical Expert

De organisatie

For Janssen Biologics Leiden and the department of RIM Data Standards, Governance & Operations Division: Labeling and Submission Management – Regulatory Information Management We are looking for a Submission Technical Expert 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 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 overall quality of output.

De functie

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 quality of output. The incumbent will be proficient in eCTD lifecycle standards and requirements. he 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 overall quality of output. Responsibilities for the function as a Submission Technical Expert:

  • 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%

Het profiel

Requirements for the function as a Submission Technical Expert:

  • 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;
  • Must have: GMP and FDA regulations experience.

RELATED EXPERIENCE:

  • 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.

Het aanbod

Full time preferred, 32 hours discussable. Role can be done mostly virtual, but candidate must be prepared to be in Leiden full time at least 2 weeks/1 month for initial training.

Inlichtingen bij

More information about the Submission Technical Expert? Please contact Leonie Koomen at leonie@heraklespharma.nl or 06-10518323

Meer informatie
Leonie Koomen Recruiter leonie@heraklespharma.nl 06-10518323