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Job #02612

About our client Our client is a reputable, mid-size CRO that is experiencing unprecedented growth. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Medical Writer Houston, Texas Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Serve as primary medical writer for one or more drug development programs 2) Plan and prepare a variety of clinical documents to support all phases of drug development (i.e., INDs, protocols, IBs, manuscripts, abstracts and other global regulatory submission documents) 3) Provide medical writing review and input for all regulatory submission documents related to specific drug development programs to ensure consistency within the given program 4) Organize, analyze, interpret as well as present scientific, clinical and statistical data 5) Ensure documents meet all ICH guidelines and company SOPs 6) Oversee document preparation by contract writers 7) Advise project team(s) on local and international medical writing issues 8) Provide time and cost estimates to Business Development for bid integration Requirements 1) Master's degree in Science 2) Advanced degree and background in scientific writing (medical, technical or regulatory) highly preferred 3) 5+ years experience as a Medical Writer in the pharmaceutical industry 4) Experience in drug development, regulatory or clinical operations with exceptional writing skills 5) Broad knowledge of international regulatory requirements 6) Articulate person with hands-on communication skills