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Principal Medical Writer
Location:
Reading
Description:
JOB DESCRIPTION Responsibilities Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus. Contributes to project plan concerning timelines as well as organization and table layout for a specific document. Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented. Review and edit documents for consistency, progression, structure, and grammar. Review statistical analysis plans and incorporate into clinical study reportsor submission documents, as applicable. Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently. Participate in team and client meetings as requested Deliverables above plus able to work independently on a range of complex clinical documents Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently Resolves complex problems independently EDUCATION AND EXPERIENCE At least 8(Ph D)-10(Masters) years of regulatory medical writing experience in the medical industry. Extensive medical writing experience inclusive of clinical study documents and global clinical regulatory submissions. Extensive authoring experience across multiple TAs in both early and late development programs. Experience authoring Health Authority responses is required. Strong project management skills required. Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences. Knowledge of current requirements and guidelines applicable to submission documents. Excellent writing skills. Excellent. Visit ListedBuy for more information.
Company:
Lifelancer
Posted:
February 24 on ListedBuy
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More About this Listing: Principal Medical Writer
Principal Medical Writer is a Other Art & Media Jobs Medical Writer Job at Lifelancer located in United States. Find other listings like Principal Medical Writer by searching Oodle for Other Art & Media Jobs Medical Writer Jobs.
Principal Medical Writer is a Other Art & Media Jobs Medical Writer Job at Lifelancer located in United States. Find other listings like Principal Medical Writer by searching Oodle for Other Art & Media Jobs Medical Writer Jobs.