Job Description
Job Description
SME, GCP Specialist, Training Content, Medical Devices
Summary
Our client, a Fortune 500 medical device company, has engaged GForce Life Sciences to provide a Senior GCP (Good Clinical Practice) Training Content Specialist to support a key project focused on refining and enhancing existing GCP training materials. This role will play an integral part in improving training effectiveness, ensuring regulatory alignment, and engaging diverse audiences across the organization—from daily operations staff to senior leadership.
Responsibilities
- Review and refine existing GCP training content, including slide decks, questionnaires, and general training materials.
- Conduct research on relevant GCP and research misconduct topics to inform content updates.
- Evaluate current content and suggest improvements for clarity, engagement, and learning effectiveness.
- Identify potential risk points in current training materials and propose mitigation strategies.
- Write and structure challenging yet achievable questions that encourage critical thinking.
- Ensure all training materials are informative, operationally relevant, and accessible to both technical and non-technical audiences.
- Align all updates with international medical device standards and regulations (FDA, ISO 14155, and other applicable GCP frameworks).
Requirements
Proven expertise in GCP-related project or content development within the medical device industry.Strong understanding of FDA and ISO 14155 regulatory requirements.Experience developing or refining training content and educational materials.Ability to translate complex GCP concepts into operational and practical applications.Skilled at creating effective learning materials, assessments, and real-world scenarios.Terms & Start
Onsite 3-4 days / week in Maple Grove, MNFull-time (40hrs / week); benefits included : health, dental, vision3+ month contractStart in January 2026Powered by JazzHR
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