The Clinical Scientist has responsibility for preparing documents on the projects they are assigned, providing critical information on progress and project needs to their management and other writers. They ensure that documents are written consistent with company and regulatory guidelines..
o With supervision, plan and prepare of a variety of clinical documents (eg; Clinical CTD modules, investigator’s brochures, clinical study reports) by organizing, critically examining, and interpreting scientific and statistical data.
o Work effectively with other writers, communicating project information in a timely manner.
o Work to ensure documents are of high quality, scientifically accurate, meet company standards and regulatory requirements (eg, SOPs ICH and FDA guidances) and reflect a consensus among team members that is acceptable to all appropriate reviewers
o Outcomes research reports and journal articles based on non-clinical and clinical studies.
o Work to ensure documents are written clearly in appropriate grammar, syntax, medical terminology, style, and format as determined by department and company guidances.
o No special physical demands.
o Major part of work done in office environment.
o High degree of accuracy and attention to detail.
o Good decision making ability.
o Demonstrated strong writing skills and has written publications.
o Ability to analyze, understand and interpret complex scientific data from a broad range of scientific disciplines.
o Knowledge of clinical drug development is an asset but not essential
o Ability to manage timelines
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