Job Description
Job Title:
Analytical SME & CMC
Technical Writer Location:
Ridgefield, CT Type:
Contract Compensation:
$45-$53.33/hr Contractor Work Model:
Remote - offsite Hours:
40.0 Overview Leading pharmaceutical company looking for an experienced Analytical SME & CMC
Technical Writer. Ideal candidates should have a minimum 6 years of experience in pharmaceutical or biotechnology CMC and analytical development for NCE and NCE-like drug substances and solid/liquid formulations Responsibilities Provide scientific leadership for phase-appropriate DS/DP analytical development and quality control activities, including method development, validation, transfer, and lifecycle management Contribute to development of analytical specifications and control strategies for drug substance and drug product in collaboration with internal teams and external partners Support DS/DP stability program design, data interpretation, and assignment of retest periods, shelf life, and material holding times for clinical development programs Independently review and contribute to quality agreements, statements of work, study protocols, analytical reports, batch records, and stability data to support CMC deliverables Prepare technical reports, presentations, and project updates for cross-functional stakeholders Partner with CDMOs, CROs, and internal teams to resolve analytical, technical, and quality-related challenges while maintaining project timelines and compliance expectations Manage documentation workflows within the Veeva RIM system to support regulatory submission activities Author, review, and edit CTD Module 3 documentation for drug substance and drug product, with emphasis on analytical content and formatting compliance Contribute to preparation of regulatory submissions, briefing packages, and responses to health authority inquiries Requirements Minimum 6 years of experience in pharmaceutical or biotechnology CMC and analytical development for NCE and NCE-like drug substances and solid/liquid formulations Demonstrated experience supporting regulatory submissions and CMC documentation activities Strong working knowledge of GMP requirements and global regulatory guidelines including ICH, FDA, EMA, USP, and EP Experience with analytical method development, validation, transfer, and stability testing Working knowledge of Veeva RIM systems and documentation workflows Strong technical writing, organizational, and document management skills High level of scientific rigor and attention to detail Ability to manage multiple priorities in a fast-paced development environment System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M- #LI- Ref:
#558-Scientific
