As a Sr. Medical Writer, you will develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles. You will actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents. Assist in working practices to allow the effective and efficient preparation of quality documents.
Job listings
$156,000–$296,500
USD/year
The Director, Strategic Medical Writing directs centralized clinical writing function across therapeutic areas and/or multiple drug programs within Development, ensuring successful preparation of high quality, submission-ready documents and effective management of the clinical writing process in accordance with clinical and regulatory timelines. Oversees business systems that support clinical regulatory document creation.