Senior Clinical Editor

IQVIA•Durham, NC

About The Position

Job Overview: Performs quality control and editing review 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

Requirements

Bachelor's Degree in English or 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
Veeva Vault
Microsoft Office (Word, Excel, Power Point, etc.)
Adobe Acrobat
ISIToolbox
SharePoint

Nice To Haves

Experience with publishing/submission-readiness a plus

Responsibilities

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