Supports all medical writing activities associated with the Medical Affairs group. Able to work independently and within Medical Affairs, as well as with project team members and the Biostatistics and Data Management staff. Job requirements are 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) and other Health Authorities.
– Draft protocols for 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.
– 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 Medical 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.
– Ensures high quality documentation with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines.
– May help to maintains quality system documents pertaining to the clinical affairs group.
– Monitors work to ensure quality, and continuously promote quality initiatives.
– 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, Microsoft Office 2010 products including Microsoft WORD, Outlook, and Power Point and the Google suite of products. Experience with EndNote and Microsoft Visio 2010 preferred.
– Excellent and proven leadership skills, team skills, written and oral communication skills.
– Strong ability to handle multiple projects simultaneously.
– Demonstrated success in technical proficiency, scientific creativity, collaboration with others and independent thought.
– Advanced technical writing skills.
– Ability to produce reports and documents independently and evaluate the writing of others.
– 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.
Must Haves: 1) Sound logic and reasoning. 2) Solid understanding of the scientific method and how to design an experiment. 3) Ability to write clearly and concisely. 4) Proficient Keyboarding. 5) Interacts well with others. 6) Capable of working independently.
Source: Job Diva – Job Listing