CMC Technical Writer Analytical Development

We are seeking an experienced an Analytical SME & CMC Technical Writer to support drug substance and drug product development programs within a leading pharmaceutical environment. Location: REMOTE (Candidates must work East Coast hours) Rate : $55-$59/hr Contract (12 months) Key Responsibilities: Provide analytical leadership for method development, validation, transfer, and lifecycle management. Support development of specifications, analytical control strategies, and stability programs. Author, review, and edit CMC documentation, including CTD Module 3 content. Support regulatory submissions (IND, CTA, NDA, MAA) and health authority responses. Manage documentation workflows within Veeva RIM. Collaborate with internal teams and external manufacturing/testing partners to ensure timely project deliverables. Qualifications: Bachelor's degree required; Master's or PhD preferred in Analytical Chemistry, Pharmaceutical Sciences, or related field. 6+ years of pharmaceutical/biotech experience in CMC and analytical development. Experience supporting regulatory submissions and technical writing activities. Knowledge of GMP and global regulatory guidelines (ICH, FDA, EMA, USP, EP). Experience with Veeva RIM strongly preferred. This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates with relevant hands-on or technical experience to apply. We look forward to learning more about you! #LI-KM1