AdresResponsibilities
• Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.
• Contributes to project plan concerning timelines as well as organization and table layout for a specific document.
• Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.
• Review and edit documents for consistency, progression, structure, and grammar.
• Review statistical analysis plans and incorporate into clinical study reports
or submission documents, as applicable.
• Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently.
• Participate in team and client meetings as requested
• Deliverables above plus able to work independently on a range of complex clinical documents
• Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently
• Resolves complex problems independently
EDUCATION AND EXPERIENCE
• At least 8(PhD)-10(Masters) years of regulatory medical writing experience in the pharmaceutical industry.
•Extensive medical writing experience inclusive of clinical study documents and global clinical regulatory submissions.
• Extensive authoring experience across multiple TAs in both early and late development programs.
• Experience authoring Health Authority responses is required.
• Strong project management skills required.
• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
• Knowledge of current requirements and guidelines applicable to submission documents.
• Excellent writing skills.
• Excellent interpersonal and oral communication skills.
• Strong knowledge of MS Word and Outlook, some knowledge of Excel and PowerPoint.
• Project management and organizational skills required including ability to manage timelines and prioritize multiple projects.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
