Medical Writing Manager
New
J
JobgetherPharmaceutical and biotechnology
Fully remote work opportunity for eligible candidates based in Canada.Full-TimeManager
Salary not disclosed
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Job Details
- Required Skills
- Project ManagementMicrosoft OfficeCross-functional collaboration
Requirements
- Have a 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.
- Have demonstrated experience in medical writing and/or document Quality Control within the pharmaceutical or biotechnology industry.
- Have practical experience working with cross-functional clinical or study teams.
- Understand medical terminology, clinical trials, and documentation used in clinical development.
- Communicate scientific and technical information clearly in writing and verbally.
- Have interpersonal and collaboration skills for working with diverse stakeholders and subject-matter experts.
- Have organizational and project-management abilities, including planning, prioritizing, and executing multiple assignments.
- Work independently, exercise sound judgment, and resolve problems in ambiguous or evolving situations.
- Be proficient with Microsoft Office applications.
- A Master's degree is highly desirable.
- Experience with data presentation and analysis software is an advantage.
- Project leadership or co-leadership experience 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, including responsible use, risk management, and ethical considerations.
Responsibilities
- Lead or co-lead medical writing and document-quality projects, managing timelines, priorities, resources, and deliverables.
- Collaborate with cross-functional study teams and subject-matter experts to develop document strategies, key messages, and scientific content.
- Review documents against source materials, including clinical and regulatory documentation and supporting data.
- Ensure deliverables meet internal quality standards, are submission-ready, and are appropriately stored and maintained.
- Lead teams of authors on complex projects, coordinate contributions, and support consistent delivery.
- Perform document Quality Control reviews and investigate and resolve quality or content issues.
- Review personal and team deliverables, seek feedback, and contribute to improvements in writing and quality processes.
- Mentor colleagues and support training on medical writing, document quality standards, and established processes.
- Share medical writing expertise, best practices, and practical guidance with colleagues.
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