Job Overview
Performs 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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