Who are you?
You are a Medical Writer who researches, writes, and edits clinical documents by applying functional expertise and clinical drug development knowledge.
• Acts as a lead medical writer on numerous programs and individual studies at a moderate to complex level.• Provides scientific and medical writing consultancy to clients and internal colleagues at a complex level.• Leads project teams in drafting report specifications, medical writing, and coordination of regulatory submissions and data analysis.• Manages all aspects of the medical writing function, including line management. • Serves as an active mentor to all levels of medical writing personnel. • Develops and implements training for medical writers.• Oversees operational activities of other medical writers as the project team leader.• Conducts in-service training for clinical research associates, other clinical functions, and clients in areas of therapeutic expertise. • Provides bid estimates for medical writing work for potential projects and attends bid defense meetings when requested.
10 years of experience in science or medical-related writing with CTD experience.Master’s degree in a science or health-related field PREFERREDOncology Submission experience To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.