Medical / Technical Writer (Yacht Life Sciences)

Medical / Technical Writer (Yacht Life Sciences)

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Medical / Technical Writer (Yacht Life Sciences)

Medical / Technical Writer (Yacht Life Sciences)

Yacht Leiden (2311AA)

Contract: Uren: 40 - 40Salaris:

Job description

Yacht Life Sciences has a vacancy for a Medical/ Technical Writer to work for Janssen Biologics B.V. in Leiden.


Are you a team player with multidisciplinary skills? Would you like to shape, and support the transition from development to a commercial product? Are you interested in data analysis and process validation? Think no more and join Janssen Biologics on their RSV challenge!


For the Biotherapeutics Development and Supply-Active Pharmaceutical Ingredient (BTDS-API) department, 2022 will be an exciting and challenging year for RSV-F with:

  • a vast array of PPQ deliverables to be completed under stringent timelines
  • the source documentation for the BLA to be completed by early April, and
  • three resupply batches for the clinic as from the 3rd quarter!


Your taks as a Medical/ Technical Writer will be the:

  • Authoring and/or reviewing of technical transfer reports
  • Authoring and/or reviewing of validation reports
  • Assist on authoring BLA filing documentation and drafting answers for questions from health authorities, support during Pre-Approval inspection (PAI)