Description
We are looking for a
Medical Writer (m/f)
Reference: -en
Start: 10/16
Duration: 6 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Manage the preparation of a suite of regulatory documents e.g. clinical dossier, suite of safety documents
- Lead writing/writing team for preparation of clinical dossiers/safety reports
- Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product/within a clinical dossier
- Prepare specifications for outsourced work (writing/review of documents) and serves as Roche liaison for project purposes
- Plan and create timelines for the production of assigned documents e.g. clinical dossier/suite of safety documents
- Ensure proper planning and resourcing of all documents assigned to writing/editing team including work to be outsourced
Your qualifications
- Demonstrated clear, high-quality scientific writing style in the English language
- Experience in regulatory affairs or related functions in drug development
- Knowledge of international regulations and previous experience of authoring and/or editing regulatory documentation
- Ability to independently analyse and synthesise data from a broad range of disciplines
Skills:
- Medical writer
Keywords: Medical Writer