Job Description

**Location: Remote** **Duration: 12 months contract** **Job Description:** + Defines scope of **quality control activities** with the **document author** and the required source documents and data required. + Conducts independent **quality control review** of documents per applicable checklist by checking against **source documents** to ensure results are accurate. **Responsibilities:** + Ensures **quality control documentation** is complete and accurate and uploaded to the **master file** per the established business processes. + Maintain strong knowledge of **clinical regulatory documents requiring quality control review** and business processes. + Interacts daily with medical writers and/or medical writing managers and interfaces/communicates with applicable cross-functional areas. + Communicates and provides deliverables to medical writers, medical writing managers, and others as applicable. **Experience:** + **2-3 years** in relevant industry experience in **quality control/review of clinical regulatory documents** or related experience in an area such as quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D. **Skills:** + Excellent knowledge of **organization and content of** **clinical documents and eCTD structure** . + Knowledge of **drug development** and experience with **Common Technical Document (CTD) content templates** . + Excellent oral/written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills. + Superior attention to detail and ability to prioritize multiple tasks/projects. + Experience in working with collaborative cross functional teams. + Operates with limited oversight. + Prepare **technical documents** to support both **domestic and international regulatory submissions.** + Incorporates text, graphs, charts, tables, and **statistical analysis.** + **Proofreads, circulates, edits, assembles, inspects, and duplicates product submissions.** **Education:** + Bachelor's degree required. + Bachelor's degree in science, English, or Communication preferred. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ( . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Tags

Contract work, Remote work,

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