Medical Writer, MedTech (UK, Home-Based) - IQVIA Biotech

The Medical Writer position supports IQVIA Biotech project teams by preparing clinical documents as requested by our clients.  These documents cover a broad spectrum of research, this role is dedicated to our MedTech team, and will span over multiple phases.    

ESSENTIAL JOB FUNCTIONS, DUTIES, AND RESPONSIBILITIES:

• Prepares Sponsor documents that include but are not limited to Clinical Study Reports, protocols, manuscripts, abstracts, Investigator’s Brochures, integrated summaries of efficacy and safety, informed consents, patient narratives, responses to health authorities, and clinical trial results posting (ClinicalTrials.gov).   
• Ensures that clinical documents comply with FDA regulations, ICH Guidelines, and appropriate SOPs. 
• Will be responsible for creating timelines associated with writing projects and will need to work within the budget assigned per project. 
• Coordinates the internal team, QC, and QA review of documents.
• Will be in direct contact with internal and Sponsor team members.
• Reviews and edits documents written by other departments, as necessary.
• Prepares clinical documents for electronic publishing.
• Explains and instructs information systems concepts and procedures to non-technical staff.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Ability to research and review clinical content effectively and translate clear and concise messages.
• Excellent communication skills (oral and written).
• Must have outstanding analytical and research skills.
• Must have the ability to decipher complex clinical and statistical data.
• Requires an understanding of clinical regulatory documentation requirements.
• Proficient computer skills, specifically with the use of MS Word templates and style features, Excel, and PowerPoint.
• Displays knowledge of standard editorial/style conventions (eg, AMA Manual of Style).
• Proven ability to manage multiple projects and to work well in a collaborative environment.
• Ability to work independently and be a team player.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very limited physical effort required to perform normal job duties.

MINIMUM RECRUITING STANDARDS:

• BS/BA or equivalent level of professional experience will be considered; knowledge of FDA and ICH guidelines.
• 3 – 6 years experience working within the biomedical and clinical writing field.
• Pharmaceutical and/or Clinical Research Organization experience is preferred.
• Success in this position requires effective interpersonal and communication skills, as the incumbent interacts directly with project team members from other departments and Sponsor team members.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.