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

We 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.

+ bonus

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