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The healthcare industry requires that we abide by regulations from all around the world. Part of the requirements is to produce clinical documents which can be used to support the safety and efficacy of our products. We are looking for individuals to write and edit clinical documents to support regulatory submissions for Baxter products.
Job Responsibility:
Develops high quality clinical documents ensuring scientific excellence and regulatory compliance
Writing, interpreting and summarizing clinical and non-clinical data
Compiling information and ensuring delivery within timelines
Ensure compliance of clinical documents with Baxter procedures, national and international regulatory requirements and guidelines
Collaborate with cross-functional team members and serve as MW representative at study team meetings
Prepare document timelines, with guidance from manager
Develop knowledge of one or more Baxter therapeutic areas
Requirements:
BS or MS in scientific or clinical discipline with excellent writing skills
2 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory
Knowledge of computer software Microsoft Word and Adobe Acrobat products
Microsoft Project and Visio are a plus
Experience in scientific and/or medical writing
Experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner
Strong organizational skills and meticulous attention to detail
Familiarity with clinical trial-related and regulatory clinical submission templates and documents
Apply global regulatory authority regulations and/or guidance
Manage multiple projects with competing priorities
Work in a team environment
Demonstrate good communication skills
Nice to have:
Knowledge of computer software Microsoft Project and Visio
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