Provide scientific writing services to Sponsors, Clinical Research Scientists, Academic partners, 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 complex technical research data and findings into regulatory documents (protocols, informed consent forms, investigator brochures, clinical study reports, etc.) on a timely basis and in alignment with industry, regulatory and academic style and content guidelines and standards. Track progress and timeline for assigned writing projects. Perform document quality control review when requested. Assist with writing or review of relevant training materials or work instruction when requested.
\n- Lead the content planning and production of regulatory documents (protocols, informed consent forms, investigator brochures, clinical study reports, etc.) that align 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 (illustrations, tables, and appendices) for publication into finished documents appropriate for the stated audience.
- Regularly track timelines and provide progress reports to stakeholder(s).
- Participate in quality control review for documents written by other authors when requested.
- Upon request, assist in the development of sales, marketing, and promotional materials.
- Will be required to translate complex scientific information, theories, practices and/or findings into clear, concise, and accurate language that can be understood by potential clients, sponsors and/or the general public.
- Develop lay summaries of study results, protocol synopses, or other study materials as required.
- 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.
- Upon request, support study teams with review, editing or proof-reading of external grant submissions, study documents or templates, such as charters, DSURs, or study plans (safety, statistical analysis, etc.).
- Assist with writing or reviewing relevant training materials or work instructions when requested.
- Minimum of an undergraduate degree (advanced degrees preferred) and 3-5 years of relevant experience in medical writing.
- Previous experience with CSRs, IBs, Protocols, and ICFs.
- Knowledge of ICH-GCP
- 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 AMA Style Guide is an asset.
- Home-based
- *Accommodations for job applicants with disabilities are available
