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Medical Writer II
Job Description
*Depending on experience
• 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
*CO/NYC candidates might not be considered
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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