Senior Clinical Editor
Barcelona, Spain | Full time | Home-based
Performs quality control review of Medical Writing deliverables from internal and external authors to ensure accuracy, consistency, and compliance with 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;
- Provide service metrics and scores, as required;
- Develop quality tools such as checklists, quality guidelines, standards and scoring methodology 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;
- Contribute to budget proposals for QC tasks and maintain a clear understanding of the time and resources needed for tasks within remit;
- 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 Life sciences related discipline or related field Req
- Master's Degree Life sciences related discipline or related field Pref
- Ph.D. Life sciences related discipline or related field Pref
- Typically, at least 8 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.