CMC Regulatory Technical Writer

　　100% Remote

　　Pay Rate: Up to $90/hr

　　Job Requirements:

　　Hands on writing experience of M3 CMC sections is mandatory

　　Scientific background (B.S or M.S.) to understand pharmaceutical drug development concepts, CMC regulatory concepts, and create documentation based on these concepts

　　Comprehensive understanding of regulations and quality guidelines to enhance probability of regulatory success and compliance

　　Demonstrated excellence in project management

　　Education and Experience:

　　Scientific background (B.S or M.S.) to understand pharmaceutical drug development concepts, CMC regulatory concepts, and create documentation based on these concepts

　　Comprehensive understanding of regulations and quality guidelines to enhance probability of regulatory success and compliance

　　Demonstrated excellence in project management

　　Key Responsibilities:

　　Author the CMC sections of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents) to support the timely submissions of investigational and marketing applications of primarily biologics

　　Contribute to global regulatory writing strategy for CMC content and drive CMC content requirements on assigned projects

　　Interpret and summarize complex data in close collaboration with technical line SMEs

　　Develop timelines, prepare and manage the review and approval of submission ready documents.

　　Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations

　　Critical review of submission documents to ensure messaging is clear and consistent within and across documents

　　Well versed in formatting using Microsoft Word and authoring tools, and perform final copyediting checks of CMC documents

　　Desired Abilities:

　　Experience in regulatory submissions, supporting the preparation of Module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents

　　Critical evaluation of analytical data with knowledge of fundamental principles of biochemistry, bioprocess, and/or pharmaceutical development

　　Good writing skills for technical content and scrupulous attention to detail

　　Excellent verbal communication skills for leading meetings and constructive remote interactions

　　Negotiate the delivery of approved technical documents in accordance with project timelines

　　Work well in team setting on a fast-paced business critical project

　　Able to work independently, strong ability to prioritize workload

　　Knowledge and experience using regulatory information management systems

　　Benefits:

　　System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

　　#M3

　　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.