Job Name: Documentation Analyst Location: New Brunswick, NJ Contractor Work Model: REMOTE Pay Rate: $39.46 Work Schedule: Mon - Fri, Business Hours Overview This role will be responsible for managing the documentation activities for marketing applications and/or post-approval regulatory submissions for cell therapy brands. This role may also require the preparation of some CMC dossier elements of regulatory filings for marketing applications and/or post-approval regulatory submissions for cell therapy brands. This position regularly interfaces with experts in Manufacturing Sciences & Technology, Analytical Sciences, Quality and Regulatory departments. This role requires effective collaboration and communication across the internal CCTM team and external department matrix teams to deliver quality regulatory submissions on time. This candidate is expected to have a good understanding of regulatory guidelines. Responsibilities + Manage document preparation of CMC regulatory submission documents to company standards + Ensure final document compliance to ensure submission content meets formatting requirements. + Author CMC elements of regulatory filings with supervision. + Participate on various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary. Requirements + Bachelor’s degree in a relevant discipline + A minimum of 4 - 7 years relevant experience OR a Masters degree with 1-3 years relevant experience. + Must possess the ability to work both independently and collaboratively in a team environment and communicate effectively in all teams. + Excellent time management and organizational skills and have the ability to navigate in electronic systems. + Working knowledge of regulatory CMC submissions, experience in Cell Therapy and CMC are a plus. + able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines. System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.