Medical Writer

The Senior Medical Writer will be responsible for tracking his/her own writing projects, and for knowing, understanding, and ensuring adherence to regulatory guidelines and department document standards. He/she will also be expected to ensure maintenance of document standardization through use of model documents/templates and appropriate peer review. The Senior Medical Writer will be responsible for reviewing documents related to the CSR, such as the Statistical Analysis Plan and draft tables, figures and listings, and ensuring that they provide the appropriate information/data for a CSR. The Senior Medical Writer will be responsible for liaising with the appropriate matrixed team members to shape and review content of documents, and to follow up with other functional groups for materials needed for document completion. The individual in this position will work independently writing CSRs, CSPs, and CSP amendments in a variety of therapeutic areas. Training on Clinical Summaries and other regulatory documents may be provided.