Senior Medical Writer

Rockville, Montgomery, Maryland
Jul 08, 2014
Aug 12, 2014
Full Time

Senior Medical Writer

MacroGenics, Inc., a growing biotechnology company, has an opening for a Senior Medical Writer in its Rockville facility.  Responsibilities include:  researching, writing, editing, and coordinating the review of medical and scientific reports (clinical and non-clinical) and documents including, but not limited to, protocols, study reports and other forms of documents filed with regulatory agencies; assisting in the development of formats and guidelines for clinical documentation; developing and maintaining document templates, formats and styles; leadership position that will have responsibility for setting up the operations strategy and work flow for the medical writing department and its interactions with other departments such as document management and information technology; serving as a departmental resource for training, mentoring, and the development of process improvements for medical writing.


Applicants must meet the following requirements: BS/BA in scientific or healthcare discipline or registered nurse and a minimum of 8 years clinical experience or advanced degree and minimum of 5 years of relevant medical writing experience in biotech, pharmaceutical or clinical research organization; ability to manage large writing projects with minimal supervision; ability to coordinate the production of deliverables and provide leadership to a project team; high degree of independence in decision making and problem solving; must possess excellent grammatical, editorial and proofreading skills and have the ability to interpret and present complex data; strong knowledge of eCTD templates (e.g. ISI writer; proficient with MS Word; experience with EDMS (e.g. Documentum, Core Dossier) a plus. 


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MacroGenics, Inc. is an Equal Opportunity Employer.