Job Overview
Performs quality control and editing of Medical Writing deliverables from internal and external authors to ensure accuracy, consistency, and compliance with data, format, and style requirements. Provides leadership, training, and guidance to staff, and assists in resource management.
Essential Functions
- Is a subject- matter expert within the group and a source of advice and information to IQVIA staff on quality control processes
- 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
- Develops quality tools such as checklists, quality guidelines, and standards to meet project- specific needs
- May have responsibility for resourcing of QC tasks within the team
- Take a leading role in providing training, guidance, and mentoring within the QC group
- May take a formal supervisory role in managing QC staff and/or contract resources
- Take a leading role in proposing, developing, evaluating, and implementing process changes and tools and monitoring their adoption and benefits
- Take a leading role in QC team meetings and ensuring that lessons learned are shared and consistent approaches are applied
- May take a leadership role for a stand-alone QC project, lead the team, and be the primary contact with the customer
- 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
- Bachelor's Degree in Life sciences -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 quality control (QC) review of clinical trial-related documents, defining and refining processes, and training and developing others
- Requires in-depth understanding of the structure, format, and purpose of a wide range of medical writing deliverables and the importance of consistency, clarity, and accuracy versus sources
- 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, investigator brochures, 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 clear and effective guidance and training in the form of written instructions, presentations, and one-to-one discussion
- 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
Technical Skills Required:
- Veeva Vault
- Microsoft Office (Word, Excel, Power Point, etc.) (see above)
- Adobe Acrobat (see above)
- ISIToolbox
- SharePoint
- Experience with publishing/submission-readiness a plus
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.