Job Description

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 This position will be responsible for managing and executing complex submission, compilation and publishing activities associated with electronic submissions and for providing subject matter expertise in eCTD implementation. Candidate experience required 5-9 years. Essential Duties and Responsibilities Compiles Nees, eCTD, or paper regulatory submissions using publishing systems. Verifies that documentation meets submission-ready standards. Ensures that all documents are filed and archived properly in accordance with Baxter requirements. Utilize a variety of software programs to format and assemble regulatory documentation for submission to health authorities. Ensure update of RIM systems with submission related milestones. Assist with the update of the publishing processes and SOPs. Participate in validation testing for RIM systems as needed. Qualifications Bachelor\'s Degree or country equivalent, scientific discipline a plus No experience in RA or related fields required, but is preferred Ability to understand changing eCTD regulations and impact to the Baxter processes and systems. Scientific knowledge a plus, must have ability to discuss technical matters with cross-functional team members Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines Exercise independent judgement Experience operating in a regulated environment. Attention to detail, organized and ability to support multiple projects Ability to learn new Technical systems (e.g. FirstDoc, ISI Toolbox, eCTDXpress, ISI Publisher, Adobe Acrobat, ISI Writer, MS Word, Excel) Ability to work in RIM for publishing and systems related activities Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our . 106525

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