Medical Writer

In this role you will be providing medical writing services and consultation to Clinical Research Scientists, Academic partners, Sponsors and/or the Corporation, which may include researching, writing, reviewing and editing scientific information, coordinating document reviews with authors, conducting reference searches and verifying citations, translating research data and findings into regulatory documents (protocols, investigator brochures, clinical study reports, informed consent forms, etc.)

and presentations on a timely basis and in alignment with industry, regulatory and academic style and content guidelines and standards. Track progress and timelines for assigned writing projects. Perform document quality control review when requested. Assist with writing or review of relevant training materials or work instructions as needed.
Clinical Research/Academic Writing Support   Lead the content planning and production of regulatory documents (protocols, investigator brochures, clinical study reports, informed consent forms, etc.) in alignment with established standards and guidelines
Work with authors/technical specialists to coordinate the completion of specialized content, to translate, write, edit and/or proof data and content (exhibits, illustrations, tables, and appendices) for publication into finished documents appropriate for the stated audience
Act as the project manager for writing deliverables and regularly track timelines and provide progress reports to stakeholder(s)
Participate in quality control review for documents written by other authors when requested
Publication Support   Act as primary contact and liaison with external publication executives, illustrators, designers, and editors, representing the Scientists/Investigators, Sponsors and/or the corporation with external specialists to select publication content, address content change requests, complete written revisions and/or resolve competing content requirements
Other Writing Support   Upon request, support study teams with review, editing or proof-reading of study documents or templates, such as charters, informed consent forms, or study plans (safety, statistical analysis, etc.)
Assist with writing or reviewing relevant training materials or work instructions when requested
Qualifications   Minimum of an undergraduate degree (advanced degrees preferred) and 3-5 years of relevant experience in medical writing
Previous experience leading the development of protocols, ICFs, and CSRs
Trained in GCP, GDPR, and HIPAA
Advanced knowledge of End Note/reference software
Familiarity with graphical software and figure development is an asset
Ability to adapt to shifting priorities and assignments
Highly refined written and oral communication skills
Demonstrated ability to work with diplomacy and tact
Previous experience/knowledge of Gastroenterology is an asset
Familiarity with ICH M11 and the AMA Style Guide is an asset
Continuous improvement mindset and willingness to embrace new technologies where appropriate

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