Medical Writer CoreLab Partners
Overview: Main responsibility involves reviewing protocols, writing Charters and Imaging Manuals, and reviewing the technical and medical components of study-related documents.
Author Independent Review Charters (Charters), Imaging Manuals (if applicable) and other study-related documents
As required, author special studies documents (Charters, Imaging Manuals (if applicable) and other study-related documents)
Assist in formatting journal article submissions (as requested) to conform to JAMA, ICMJE and AMA style guidelines. Review content as required.
Collaborate with the Associate Medical Writer in creating Imaging Manuals and other studyrelated documents. Review documents prepared by the Associate Medical Writer. Review consistency between the Charter and the Imaging Manuals/study-related documents prepared by the Associate Medical Writer
Collaborate with Sponsors, RadPharm Project Managers and Medical Staff in reviewing protocols and proposals prior to authoring, editing and revising study-specific Charters
Collaborate with Sponsors, RadPharm Project Managers and Medical Staff in reviewing the medical and technical components of study-related documents such as the Imaging Manuals (if applicable), Charter Training Slides, Source Document Instructions, etc.
Participate in the development and review of study-related document templates such as Imaging Manuals, response criteria-specific charter templates
Participate in the development, review and evaluation of Medical Communications and Clinical Operations SOPs
Review the consistency between study-related documents such as Proposals, Protocols, Charters, Imaging Manuals , Source Document Instructions, etc.
Assist in the clerical duties associated with Charter Development (i.e., file conversion to PDF format, posting Protocols, Imaging Manuals, Charter Training Slides, Source Document Instructions, response criteria, journal articles, and other references to the T: drive, as necessary)
Stay current with FDA requirements related to the Medical Imaging Charters
Stay current with the language in the Charter templates and the various response criteria used (RECIST, Cheson, WHO, etc.)
Update the Medical Communications Charter and Imaging Manual database each time a charter is assigned/revised/finalized
Maintain the Medical Communications web pages (as needed) for Charters, Protocols, IQA Summaries, Imaging Manuals and Charter Training Slides
Other functions as assigned by the Manager, Medical Communications; Director, Clinical Operations Support; and the Vice President, Medical Affairs Radiology
Bachelors Degree in either Life or Physical Sciences
Minimum 3 years experience in pharmaceutical research and/or imaging core lab
Medical/pharmaceutical/regulatory/clinical writing experience preferred
Ability to effectively and efficiently manage multiple projects simultaneously
Self-directed, flexible and adaptable to changing priorities
Outgoing, friendly, professional
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