Quality Control Reviewer, South Africa

1 month ago

Bloemfontein, South Africa IQVIA Full time

**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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