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 EndNote/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
Stay Alert to Recruitment Scams
We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.
