Principal Medical Writer, Bridgewater, NJ - (Bridgewater, NJ)

The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive background with the preparation of clinical documents and regulatory dossiers and has demonstrated leadership skills as submission lead. As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole and individual clinical studies. More specifically the position holder, is responsible for the timely preparation and/or coordination, in English, of reports and/or related regulatory documentation (in some cases of extremely time-critical documentation), required for the planning, initiation, performance and reporting of clinical studies and for marketing approvals worldwide.