Improved precision, clarity, and structure in CMC and GMP documents and regulatory reports
CHALLENGES
Three out of five employees at Vertex Pharmaceuticals are dedicated to the research and development of new medicines.
Senior leadership wanted to improve the clarity of Chemistry, Manufacturing, and Controls (CMC) and Good Manufacturing Practices (GMP) documents. Regulatory filings lacked structure and required multiple rounds of rewrites before they were ready for submission to the FDA.
SOLUTIONS
This training for 60 Vertex scientists and engineers was delivered virtually and included group instruction, breakout sessions, and individualized written feedback.
Participants learned to structure content thoughtfully and include relevant information, with awareness of regulatory review. Vertex employees learned to extract and summarize highly technical information for leadership, regulatory review, and quality assurance. This ensured that each audience received the information and implications they actually needed, in succinct, non-technical language that reduced risk by improving clarity and accuracy.
OUTCOMES
Reduce writing time by over 20%
Vertex will save an estimated $281,250 annually, based on 60 participants trained with an average salary of $50k and three hours a day spent writing.
Highly relevant curriculum for a fast-paced, global team
Fully remote participants shared in a unified training experience. The instructor-led virtual course, accessible from anywhere in the world, was customized to address Vertex’s documents and goals while considering their training culture.
Testimonial from a Senior Manager at Vertex
“The major benefit was understanding the importance of who you are writing to (audience) and what you need them to know (content). [We learned] to create professional and concise emails, reports, and documents in general (less wordy, proper tone and syntax).”