What are the responsibilities and job description for the Medical Writer II position at Katalyst CRO?
Responsibilities
- 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.
- 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.
- Bachelor's degree required.
- Bachelor's degree in science, English, or Communication preferred.
- 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. Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
- 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.
- Prepares 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.
- Experience Level = 3-5 Years.
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