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Adjunct Faculty - Regulatory & GxP Writing for Life Sciences
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Part-time
bachelor degree, postgraduate degree
Posted 42d ago
~40 hrs/week
Responsibilities
Develop and teach a four-week asynchronous online course on regulatory and GxP writing for life sciences professionals. Responsibilities include creating course content, providing feedback on writing assignments, and facilitating virtual discussions on compliance documentation.
Requirements
Requires a bachelor's degree and professional experience writing or reviewing GxP documentation in a regulated life sciences environment. Candidates must demonstrate expertise in regulatory submissions and the ability to teach in an online format.
Full job description
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.
Qualifications
Required
Bachelor’s degree required. Advanced degree in a relevant field (e.g., life sciences, regulatory affairs, quality, or related discipline) preferred.
Professional experience in a regulated life sciences environment with direct responsibility for writing or reviewing GxP documentation (e.g., SOPs, deviations, CAPAs, reports, or regulatory submissions).
Demonstrated understanding of GxP principles and documentation requirements, including accuracy, traceability, and audit readiness.
Excellent written and verbal communication skills, with the ability to teach and model clear, concise, and compliant writing.
A commitment to learner success and to engaging learners in an online format.
Comfort with ambiguity and effective problem-solving in the context of launching and refining a new course offering
Desired
Experience teaching or developing professional education programs (in-person, virtual, or hybrid).
Experience with a learning management system, such as Blackboard.
Highlighting initiatives, innovations, and achievements within the School of Pharmacy-Boston
Industry
Higher Education
Company size
51-200 employees
Headquarters
Boston, Massachusetts
LinkedIn followers
1,579
Founded in 1823, Massachusetts College of Pharmacy and Health Sciences is the second-oldest university of pharmacy in the United States and has prepared more students for careers in pharmacy than any other university in the world. The School of Pharmacy-Boston is committed to the development and delivery of quality programs that prepare a culturally diverse student body to become qualified practitioners of patient-centered care, services and research in the pharmaceutical professions and maintaining a multidisciplinary environment conducive to excellence in teaching, scholarship and professional advancement. This page is managed by the school's Faculty Development and Recognition Committee and serves to promote initiatives, achievements, and successes.
Offices: 179 Longwood Ave, Boston, Massachusetts 02115, US
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