Medical Writer

Contract Clinical Medical Writer in Cambridge, MA.

Responsible for planning content and format of documents; completing clinical study reports within established schedules and timelines; interacting with project physicians, statisticians and programmers, clinical operations and regulatory personnel. In collaboration with the clinical teams, research, write and edit clinical study protocols, clinical study reports, Investigator's Brochures and other clinical documents/regulatory submissions; compile appendices to clinical study reports. Maintaining awareness of overall developments in the field of clinical research and in particular expertise in state-of-the-art clinical study design and data reporting.

Keywords: Clin*, MW, Regulatory, Pharmaceutical, Biotech, Protocol, Massachusetts, IND, IB.
REQUIREMENTS
Relevant science degree with a 2-3 years pharmaceutical medical writing experience in a pharmaceutical company. Have a clear, high quality scientific writing style in the English language, and have the ability to independently analyze and synthesize data from a broad range of disciplines. Must have knowledge of statistics and safety information, as well as the ability to coordinate and prioritize multiple projects and communicate effectively in a fast-paced environment. Experience compiling clinical study protocols, reports and clinical summaries is a must. Knowledge of current FDA/EMEA/ICH regulatory requirements for the reporting of clinical trial data and integrated summaries for regulatory submissions.