Medical Writer (m/f)

REFERENZNUMMER:

317662/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Medical writer