Medical Writer with strong knowledge and experience (at least 5 years) in early phase study documents (Clinical Study Protocol, Clinical Study Report) in particular healthy volunteer PK/PD studies.
• Ability to coordinate vendor resources and to track timelines and priorities of documents together with safety project management.
• Strong communication skills (verbal, written, and listening) with the ability to interpret and summarize complex data.
• Technical expertise in Microsoft Office suite, MW Word templates, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
• Ability to maintain familiarity with current industry practices, regulatory requirements, and guidelines that affect Medical Writing.
• Strong organizational skills.
• Excellent time and priority management; ability to work efficiently under pressure. Strong presentation skills and adapting to a variety of audiences. Acts ethically, ensures quality, and creates customer value. Fluent in English (oral and written).