Medical Writing Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Medical Writing Manager based in Canada. This role offers the opportunity to shape scientifically rigorous medical content that supports evidence-based healthcare decisions and better patient outcomes. You will lead moderately complex medical writing and document-quality projects within a collaborative, cross-functional environment. The position combines hands-on scientific writing and quality control with project coordination, stakeholder collaboration, and team leadership. You will ensure critical documents are accurate, compliant with internal standards, submission-ready, and supported by reliable clinical and regulatory evidence. The role also provides opportunities to mentor colleagues, contribute to training, and influence document strategies and best practices. You will work independently while applying sound judgment to resolve challenges and navigate ambiguity. This is a strong opportunity for an experienced medical writing or document quality professional seeking meaningful impact within pharmaceutical or biotech development.

Lead or co-lead moderately complex medical writing and document-quality projects, managing timelines, priorities, resources, and deliverables effectively. Collaborate with cross-functional study teams and subject-matter experts to develop document strategies, key messages, and high-quality scientific content. Review and verify documents against source materials, including clinical and regulatory documentation and supporting data, to ensure accuracy and consistency. Ensure deliverables meet applicable internal quality standards, are submission-ready, and are appropriately stored and maintained. Lead teams of authors on complex projects, providing direction, coordinating contributions, and supporting consistent delivery. Perform document Quality Control reviews and identify, investigate, and resolve quality or content issues. Apply professional judgment to resolve moderately complex problems and operate independently when requirements or circumstances are ambiguous. Review personal and team deliverables, actively seek feedback, and contribute to continuous improvement of writing and quality processes. Mentor colleagues and support training initiatives related to medical writing, document quality standards, and established processes. Serve as a knowledgeable resource for colleagues by sharing expertise, best practices, and practical guidance. Contribute to broader departmental priorities and initiatives by applying relevant medical writing, scientific, and operational expertise. Requirements Bachelor's degree in a relevant field, or an MBA/MS with relevant experience; alternatively, a PhD/JD with relevant experience, an Associate's degree with substantial relevant experience, or a high school diploma/equivalent with extensive relevant experience. Demonstrated experience in medical writing and/or document Quality Control within the pharmaceutical or biotechnology industry. Practical experience working with cross-functional clinical or study teams. Solid understanding of medical terminology, clinical trials, and the documentation used in clinical development. Strong written and verbal communication skills, with the ability to communicate scientific and technical information clearly. Excellent interpersonal and collaboration skills, with the ability to work effectively with diverse stakeholders and subject-matter experts. Strong organizational and project-management abilities, including planning, prioritizing, and executing multiple assignments within defined objectives. Ability to work independently, exercise sound judgment, and resolve problems effectively in ambiguous or evolving situations. Proficiency with Microsoft Office applications. A Master's degree is highly desirable. Experience with software used for data presentation and analysis is an advantage. Experience leading or co-leading projects is preferred. Experience training or mentoring colleagues on quality standards and processes is an asset. Familiarity with generative AI tools such as ChatGPT or Microsoft Copilot is a plus, particularly for improving productivity and problem-solving while understanding responsible AI use, risk management, and ethical considerations. Benefits Fully remote work opportunity for eligible candidates based in Canada. Flexible working environment designed to support work-life harmony and individual working needs. Opportunities to contribute to projects with meaningful impact on healthcare decisions and patient outcomes. Professional development and opportunities to expand expertise in medical writing, quality, clinical development, and emerging technologies. Opportunities to mentor colleagues and participate in training and knowledge-sharing initiatives. Collaborative, cross-functional environment with exposure to scientific, clinical, regulatory, and operational experts. Inclusive workplace culture that values diverse perspectives, individual strengths, and equitable opportunities. Opportunities to engage with digital transformation initiatives and emerging data, automation, and AI-enabled approaches. Reasonable workplace accommodations and support for candidates with disabilities. Opportunity to work on scientifically significant projects supporting the safe and appropriate use of medicines.

laptop-ats-crawler v3