Job OverviewPerforms quality control review of Medical Writing deliverables from internal and external authors to ensure accuracy, consistency, and compliance with format and style requirements.Essential Functions• Conduct quality control (QC) review of a wide range of Medical Writing deliverables for both internal and external customers, including complex and substantial documents, with limited guidance and consistent high quality and efficiency;• Document findings clearly, in accordance with defined procedures and checklists;• Liaise promptly with document authors in case of questions or missing sources;• Provide service metrics and scores, as required;• Develop quality tools such as checklists, quality guidelines, standards and scoring methodology to meet project specific needs;• Identify quality issues and assist management team in implementing solutions;• May provide training, guidance, and/or mentoring reviews to junior colleagues or explain QC processes to team members or customers;• May propose revisions to standard operating procedures (SOPs) related to QC review or suggest process improvements for consideration;• Contribute learnings to team meetings and help in improving overall quality of document delivery;• May participate in project team meetings and liaise directly with the customer on QC issues, as appropriate and with senior support as needed;• Take responsibility for on-time delivery of QC review comments;• Manage daily assignments, planning and directing work, and take responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff;• Keep abreast of current data, trends, medical writing (MW)/regulatory knowledge, developments and advances in area of drug development/MW.Qualifications• B Sc Degree in Life science-related discipline or related field;• Typically, at least 4 years' experience working with clinical trial documentation in a research environment, including significant experience of performing QC review of clinical trial-related documents;• Careful attention to detail, accuracy, and consistency;• Impeccable English language skills and ability to detect and correct grammatical, spelling, and language errors;• Ability to understand scientific/medical documents and identify deficiencies, errors and inconsistencies;• Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents;• Proactivity and advanced organizational and time management skills and ability to prioritize workload effectively with commitment to deadlines;• Ability to communicate clearly, concisely, and effectively in English, both in writing and verbally, and confidence in using a range of communication methods to achieve results;• Good understanding of clinical drug development and the functions, steps, and processes involved;• Advanced understanding of the nature and purpose of Medical Writing deliverables;• Ability to provide thorough, appropriate, and sensitive feedback to less experienced colleagues;• Confident use of Microsoft Office and Adobe Acrobat;• Ability to quickly establish and maintain effective working relationships with co-workers, managers, and customers at a range of seniority levels.
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