Senior Clinical Medical Writer
November 18
Description
• Responsible for creating high quality clinical research related documents in compliance with regulatory requirements. • Write documents including complex submission-level clinical documents. • Acquire knowledge of therapeutic areas, competitor devices, and current clinical/market developments. • Ensure consistency and quality of all documents. • Create and maintain regulatory documents related to clinical data. • Plan and execute structured literature searches and analyze relevant clinical data. • Review the literature and interpret and summarize risks, alternative therapies, and device-specific benefits.
Requirements
• Master’s degree in life sciences and 3+ years of medical writing experience at a medical device, biotechnology or contract research organization; or BS degree with 5+ years of experience. • Understanding of world-wide clinical related regulations and guidance documents. • Expertise in MS Word, Excel and PowerPoint. • Demonstrated analytical skills and interpretation of clinical data. • Excellent verbal and written communication skills. • Strong attention to detail and exceptional follow-through. • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization. • Ability to work and excel within a fast-paced, dynamic, and continuously changing work environment. • Solid project management and organizational skills with the capacity to prioritize and multi-task.
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