Job Description

• With supervision, plan and prepare of a variety of clinical documents (e.g.; Clinical CTD modules, investigator’s brochures, clinical study reports) by organizing, critically examining, and interpreting scientific and statistical data.
• Work effectively with other writers, communicating project information in a timely manner.
• Work to ensure documents are of high quality, scientifically accurate, meet company standards and regulatory requirements (e.g., SOPs ICH and FDA guidance’s) and reflect a consensus among team members that is acceptable to all appropriate reviewers
• Outcomes research reports and journal articles based on non-clinical and clinical studies.
• Work to ensure documents are written clearly in appropriate grammar, syntax, medical terminology, style, and format as determined by department and company guidance’s.

Skills Requirement
• Good decision making ability.
• Demonstrated strong writing skills and has written publications.
• Ability to analyze, understand and interpret complex scientific data from a broad range of scientific disciplines.
• Knowledge of clinical drug development is an asset but not essential
• Ability to manage timelines
• Ability to work under pressure & flexibility to meet demanding deadlines essential.
• Flexible to work in any 9 hour shift

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