Trilogy

Medical writer

• Write, edit, and review complex CMC regulatory documents, including Module 3 (Quality) of the eCTD, Quality Overall Summaries (QOS), and briefing books.
• Interpret and summarize technical data from analytical development, drug substance, and drug product manufacturing, ensuring consistency with regulatory standards.
• Ensure all documents adhere to ICH, FDA, and EMA regulations.
• Drive development of the CMC outputs by generating and reviewing CMC outputs from our medical writing platform and working with the AI development team to improve the quality of the outputs.
• Lead CMC writing teams, coordinating inputs from diverse departments such as Manufacturing, Quality Assurance, Regulatory Affairs, and CMC technical teams.
• Perform rigorous peer reviews and final quality checks on documents to ensure scientific accuracy, clarity, and grammatical correctness.
• Provide guidance, training, and mentorship to junior medical writers.

Principal Medical Writer – CMC

• Write, edit, and review complex CMC regulatory documents, including Module 3 (Quality) of the eCTD, Quality Overall Summaries (QOS), and briefing books.
• Interpret and summarize technical data from analytical development, drug substance, and drug product manufacturing, ensuring consistency with regulatory standards.
• Ensure all documents adhere to ICH, FDA, and EMA regulations. Collaborate with Regulatory Affairs to develop submission strategies.
• Drive development of the CMC outputs by generating and reviewing CMC outputs from our medical writing platform and working with the AI development team to improve the quality of the outputs.
• Lead CMC writing teams, coordinating inputs from diverse departments such as Manufacturing, Quality Assurance, Regulatory Affairs, and CMC technical teams.
• Perform rigorous peer reviews and final quality checks on documents to ensure scientific accuracy, clarity, and grammatical correctness.
• Provide guidance, training, and mentorship to junior medical writers.