Supports all medical writing activities associated with the Clinical Affairs group. Able to work independently with project team members and the Biostatistics and Data Management staff to draft, edit, and finalize a variety of documents including study protocols, presentations, manuscripts for peer-reviewed publications, clinical study reports and submissions to the Food and Drug Administration (FDA).
ESSENTIAL FUNCTIONS: –
Designs scientifically sound studies in conjunction with project teams in Biostatistics and Data Management to support new product development in molecular probes, immunohistochemical reagents and new instrument platforms. – Drafts clinical study protocols and study reports. Provides editorial assistance in support of scientific publications and/or post-marketing study activities. – Interfaces with Regulatory Affairs and other groups to ensure the accuracy and timely review and revision of all cross-functional documents supporting regulatory submissions. –
Develops scientific expertise in the application of new diagnostic reagents to personalized healthcare. – Educates members of the Clinical Affairs staff in the area of effective visual and written communication; ensures content contained in all documentation conforms to company design control and legal requirements. – Supports one or more clinical development programs. – Ensures high quality documentation with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines. – Maintains quality system documents pertaining to the clinical affairs group. – Monitors work to ensure quality, and continuously promote Quality First Time. – May perform other duties as required or assigned.
Knowledge, Skills, and Abilities: –
Expert knowledge and application of scientific principles and concepts. – Demonstrated proficiency in typing, use of Adobe Acrobat 9 Pro and Microsoft Office 2010 products including Microsoft WORD, Outlook, and Power Point. Experience with EndNote X2.0 and Microsoft Visio 2010 preferred. –
– Advanced technical writing skills. – Ability to produce reports and documents independently and evaluate the writing of others. –
Demonstrated creativity and ingenuity through the development of Client, multi-disciplinary approaches to projects and strategic issues. – Skill and ability in implementing strategic projects, acting as a catalyst to remove organizational barriers, reduce cycle times and direct process improvements. – Ability to rapidly develop expertise in FDA guidelines for in vitro diagnostic devices and the statistical basis for sensitivity, specificity and reproducibility testing required for validation and FDA clearance and approval. – Ability to rapidly develop expertise in the company’s internal document management system.
Source: Job Diva – Job Listing