Adjunct Faculty - Regulatory & GxP Writing for Life Sciences

The School of Professional Studies is seeking an adjunct instructor to develop and teach a short-format course titled Writing for Compliance: Regulatory & GxP Writing for Life Sciences. This offering is designed for early- to mid-career professionals working in quality, regulatory affairs, manufacturing, CMC, and related technical roles who are responsible for producing clear, compliant documentation in regulated environments.

The course provides a practical, application-focused introduction to regulatory and GxP writing, emphasizing how documentation supports compliance, audit readiness, and product quality. Key topics include the structure and lifecycle of controlled documents (e.g., SOPs, deviations, CAPAs), writing for regulatory submissions and CMC documentation, and applying plain-language principles to technical and patient-facing materials. Learners will develop hands-on skills through applied writing exercises, document critique, and iterative feedback. By the end of the course, participants will produce a small portfolio of compliance-ready writing samples demonstrating clarity, accuracy, and adherence to regulatory expectations.

The course is delivered over four weeks in a fully online format, combining asynchronous content with applied assignments and peer interaction. The course is expected to launch in November 2026. Candidates should be comfortable facilitating applied, feedback-driven learning in a virtual environment.

• Teach approximately 12-14 hours total, aligned with a four-week asynchronous online course format.
• Develop course content (approximately 48 hours), including micro-lectures, case studies, discussion prompts, and short knowledge checks.
• Deliver applied instruction on topics such as GxP documentation principles, SOP development, CAPA writing, regulatory submission writing (e.g., CTD/CMC), and plain-language communication.
• Guide learners through hands-on writing exercises, including drafting, revising, and evaluating compliance-focused documents.
• Provide clear, actionable feedback on written assignments to support skill development and improvement.
• Design and administer assessments aligned with course outcomes (e.g., SOP excerpt, deviation write-up, short regulatory writing sample, final writing portfolio).
• Facilitate discussion and reflection on documentation quality, audit readiness, and common writing pitfalls in regulated environments.
• Create an inclusive and engaging online learning environment that supports professionals with varying levels of writing experience.
• Ensure the course meets the high-quality standards of MCPHS professional and online education.
• Review learner feedback and engagement data to support continuous course improvement.