Medical Writer

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

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. The ideal candidates must have a scientific background and be fluent in English (both writing and speaking).

What you'll be doing

• With oversight, develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes writing, interpreting and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines.
• Clinical documents may include protocols, clinical study reports, investigator brochures, integrated reports, clinical sections of core technical documents/new drug applications/briefing documents per regulations.
• 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.

What you'll bring

• 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

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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