Job Highlights
Not Disclosed
Posted 1 year ago
Job details
Responsibilities
- 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
- 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
- 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.
Benefits Offered?
- No
Bonus Offered?
- No
Travel Required?
- No
Location:
- Community of Madrid - Spain
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 12, 2024
Company Overview
IQVIA
Current Openings: 0
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.
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