Medical Writer - Sponsor dedicated

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Provides scientific/regulatory guidance and technical expertise in the writing, production, and review of regulatory and other scientific/clinical documents. Serves as medical writer on clinical study. Plans and coordinates report-writing activities with dependent staff roles to ensure satisfactory completion of all writing projects, as well as mentors and leads less experienced medical writers on complex projects

Job responsibilities:

• Compiles, writes, and edits medical writing deliverables
• Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas, in specific study synopsis, study protocol, abstracts, poster and manuscripts.
• Advises study teams on data presentation and production strategies and on data interpretation as needed.
• Interacts with cross-functional team, data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Serves as peer reviewer on internal review team.
• Established regulatory standards, including but not limited to ICH-E6 guidelines, as well as company SOPs, approved templates when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Mentors and leads less experienced medical writers on complex projects, as necessary.

Essential Qualifications

• Background in a scientific or medical discipline.
• At least, 1.5 years of experience as a Medical Writer in Clinical Research
• Extensive knowledge of English grammar with a familiarity with a standard style guide
• Ability to communicate scientific or medical information in a clear and concise manner
• Familiarity with the principles of clinical research
• Ability to interpret and present clinical data
• Advanced degree within the field
• Professional certification
• Understanding of multiple aspects within Study Management
• Officebased

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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.