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Show me jobs like this one| Job Ref: | . |
| Sector: | Pharmaceutical and Medical Device |
| Job Type: | Full Time |
| State: | Pennsylvania (PA) |
| City: | Exton |
| Post Code: | Feb 17, 2012 |
| Job Description: |
ViroPharma Incorporated is an international biotechnology company with headquarters in Exton, Pennsylvania committed to developing and commercializing innovative products that address unmet medical needs. We are comprised of a community of People united by their commitment to improve the health of patients suffering from serious diseases. Over the past 16 years we have built and cultivated a value-based culture of excellence, both in our United States and in European operations. We are currently seeking People with the following expertise: PRINCIPAL MEDICAL WRITER Principal Objective(s): The Principal Medical Writer researches, writes, and edits complex clinical documents for submission to regulatory agencies and for publication and/or presentation to meet the objectives of Clinical Research and Development (CRAD). Major Duties and Responsibilities: - Preparation of all sections of phase 3 clinical study reports, integrated summaries of safety and efficacy, and other high level clinical summary and overview documents for submission to regulatory agencies. - Preparation of investigator brochures, annual reports, and other clinical sections of an IND. - Preparation of clinical protocols (phase 1-3) as part of the CRAD team. - Ensure that all documents are authored using appropriate ViroPharma Style Guides, templates, and departmental SOPs. - Review draft case report forms as part of protocol development to ensure all appropriate data are captured. - Review statistical analysis plans. - Function as lead writer for a project. - Attend project team meetings, and provide medical writing expertise and guidance to team. - Task manage / mentor the activities of less experienced personnel. Requirements Experience |
| Post Date: | 02/18/2012 |
