The position will be a member of the Quality and Publishing team in the Medical Writing department. This position reports to the Quality and Publishing Senior Manager. Under the general supervision of the Senior Manager this position works collaboratively and closely with Medical Writers and is responsible for editorial support of clinical regulatory documents created by in-house Medial Writers and by Medical Writing vendors to produce high-quality documents and ensure that documents adhere to internal and global quality standards and are in accordance with electronic publishing standards.

Responsibilities

Provide editing and styling / formatting support to Medical Writers for clinical regulatory documents  (eg, CTD Submission documents, Clinical Study Protocols, Investigator’s Brochures, Clinical Study Reports, Clinical Study Outline, etc).  Edit to align according to department’s Style Guide, document-specific template, and publishing requirements.Document is styled and formatted consistently throughout the document and related documents (eg,  StartingPoint Styles are used throughout the document).Provide editing support to other functions (other clinical / regulatory documents [eg, SAP, CDP, Briefing Book]) as needed.Adhere to guidelines, SOPs, practices, and industry standards during all aspects of work.Support developing and reviewing standard processes and templates as needed.Ability to meet deadlines while maintaining high quality standard..

Essential skills / Experience requirements:

A least 3 years of editing experience in pharma and / or healthcare industry.Advanced document formatting and editing knowledge in Microsoft Word (MS Office suite).Proficient in StartingPoint Templates suite and styles.Strong proofreading skills.Proficient in Adobe Acrobat.Basic familiarity of the drug development process and Good Clinical Practice (GCP).Knowledge of routine document preparation, including the use of style guides, regulatory guidance documents and templates.Familiar with the AMA Manual of Style.Demonstrate ability to multi-task in a fast-paced environment under strict timelines.Flexible, open-minded, and detail-oriented.Excellent verbal and written communication skills.Experience working in Microsoft Teams and SharePoint.Experience using Regulatory / Electronic Document Management Systems (eg, Documentum).Experience with ISI toolbox and publishing is 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