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Senior Medical Writer
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- Reporting to the Sr. Director, Medical Writing, the Senior Medical Writer is responsible for researching, planning, writing, and editing medical writing deliverables that support clinical development and regulatory writing objectives; works with minimal guidance to achieve goals; and is recognized as a scientific contributor and subject matter expert in preparation of selected clinical/regulatory documents.
- The successful candidate will be the main coordinator and lead writer for documents such as clinical study protocols, clinical study reports, investigator’s brochures, summary sections of regulatory submissions.
- Manages medical writing projects to prepare clinical/regulatory documentation (e.g., clinical study protocols, clinical study reports, investigator brochures, regulatory submission modules) in support of clinical development, clinical studies, and regulatory submissions, presenting clinical data objectively and clearly in a concise format consistent with industry guidelines
- Requires a Bachelor’s degree in science or English/Communications (PhD, PharmD, or Master’s degree highly preferred) with significant relevant scientific experience, a minimum of 6+ years relevant pharmaceutical and/or medical device industry experience, and at least 3+ years of specific medical writing experience in the pharmaceutical industry (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/BLA/NDA sections)
- Ability to lead/manage multiple projects in a fast‐paced environment handling multiple demands and experience with project management software (e.g., MS Project, Smartsheet)
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