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We are looking for individuals to write and edit clinical documents to support regulatory submissions for Baxter products. The ideal candidates must have a scientific background and be fluent in English (both writing and speaking).
Job Responsibility:
Develop high quality clinical documents ensuring scientific excellence and regulatory compliance
write, interpret and summarize clinical and non-clinical data
compile information and ensure 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, as needed
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 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 Microsoft Project and Visio
2 years of on-the-job experience in scientific/medical writing.
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