Medical Technical Writer
What are we looking for?
An experienced Medial Technical Writer to join a dynamic team and helping to develop, draft, review, edit and finalize documents used in conducting clinical studies and reporting. You will be responsible for the development and execution of a number of key pieces across multiple business units.
As the Medial Tech Writer, you will draft and edit documents using in conducting and reporting the results of clinical studies, including protocols, protocol amendments, consent forms and clinical study reports. You will also conduct comprehensive literature evaluations, product complaint reviews and other product specific information.
How will you make an impact?
- Manage study team participation in the preparation of such documents – this will include calling/running meetings, developing timelines and managing the document review and comment adjunction processes
- Provide peer review and editing support for other regulatory documents (such as statistical analysis plans, CRFs and other study materials)
Experience & Qualifications
- 2 years of medical writing experience in the medical device industry
- 5+ years of medical writing experience – writing, reviewing and editing
- Knowledge of routine document content preparation (style guides, medical dictionaries and guidance documents)
- Knowledge of AMA, CBE and Chicago Style Manuals
- Interpret basic tabular and graphical clinical data presentations
- Create basic tables using AMA style
- Knowledge of basic clinical laboratory tests
- Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
- Understanding of biostatistical and clinical research concepts
Posted 6d ago
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