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.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 SupportLead the content planning and production of regulatory documents (protocols, investigator brochures, clinical study reports, informed consent forms, etc.) in alignment with established standards and guidelinesWork 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 audienceAct 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 requestedPublication SupportAct 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 requirementsOther Writing SupportUpon 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 requestedQualificationsMinimum of an undergraduate degree (advanced degrees preferred) and 3-5 years of relevant experience in medical writingPrevious experience leading the development of protocols, ICFs, and CSRsTrained in GCP, GDPR, and HIPAAAdvanced knowledge of EndNote/reference softwareFamiliarity with graphical software and figure development is an assetAbility to adapt to shifting priorities and assignmentsHighly refined written and oral communication skillsDemonstrated ability to work with diplomacy and tactPrevious experience/knowledge of Gastroenterology is an assetFamiliarity with ICH M11 and the AMA Style Guide is an assetContinuous improvement mindset and willingness to embrace recent technologies where appropriate+ bonusWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

📌 Medical Writer (Montreal)
🏢 Alimentiv
📍 Montreal