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.
Requirements:
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.
Compensation: N/A
Additional Details :
Apply
Please attach a cover letter and a curriculum vitae/resume. Finalist candidate(s) for this position will be subject to reference checks and a pre-employment background check as a condition of employment.
Applicants must be authorized to work for any employer in the U.S. MCPHS is unable to sponsor, or take over sponsorship of an employment Visa. MCPHS is also not an E-Verify institution.
About Us
Established in 1823, Massachusetts College of Pharmacy and Health Sciences (MCPHS) is the oldest institution of higher education in Boston, a city that is home to many of the world's top universities and healthcare institutions. We are one of the largest and most highly-ranked schools for health and life sciences, and our alumni and faculty continually distinguish themselves in healthcare settings around the globe. MCPHS has more than 7000 students across campuses in Boston's Longwood Medical and Academic Area (LMA), downtown Worcester, MA and downtown Manchester, NH. Our vision is to empower our Community to create a healthier, more equitable world, which we strive to achieve through our core values of integrity, community, engagement, collaboration, support, and innovation.
MCPHS is an equal opportunity employer dedicated to ensuring equal opportunity for all members of the University community. We aim to recruit, develop, and retain the most skilled faculty and staff. All qualified applicants will be considered for employment.
