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Principal Medical Writer

3 months ago

Remote, United Kingdom IQVIA Full time

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

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.