Sr. Medical Writer at Cambridge

Job Description

A Major Pharmaceutical Company is looking for a Sr. Medical Writer in Cambridge, MA.Duties: The primary purpose of this job is independently to create, or manage creation of, any type of clinical regulatory document according to company guidelines and international regulations and to present data objectively in a clear, concise format. This is a position for an independent, proactive, experienced medical writer who has demonstrated leadership in the preparation, editing, and reviewing of diverse regulatory documents (including summary submission documents) and who has led submission projects. As a key participant in document preparation or submission teams, the position holder manages the quality, compliance with internal and external standards, and the timely production of English-language documents using the electronic document management system. The position holder contributes scientific knowledge, analytical skills, people and process management, submission experience, and regulatory knowledge to the analysis of data, preparation of documents, and planning and production of regulatory dossiers.Skills: Substantial experience preparing a range of summary submission documents including both clinical and non-clinical content. Accurate and detail-oriented, with excellent inter-personal skills. Demonstrated ability to lead others to complete projects. Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management, and medical terminology. Specialized knowledge of at least one therapeutic area and/or relevant technical specialty. Native English speaker or have proven excellent spoken and written English. Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system. Ability to lead and motivate medical writing teams in a cross-cultural, geographically dispersed environment. Demonstrated creativity, problem-solving ability, and sense of urgency. Demonstrated ability to plan, organize, and prioritize tasks; to work simultaneously on multiple projects; and to manage others in completing large projects according to timelines.Education: University degree in science (preferably advanced) or equivalent qualification and experience (preferably >9 years) as a medical writer or equivalent.

Job Requirements

 
Country: USA, State: Massachusetts, City: Cambridge, Company: InVentiv Health.