Sr Specialist, Regulatory Affairs (Open to Remote)Req # JR - 068388 Location Deerfield, Illinois, United States (Remote) Additional locations Tennessee (remote); South Dakota (remote); South Carolina (remote); Rhode Island (remote); Pennsylvania (remote); Oregon (remote); Oklahoma (remote); Ohio (remote); North Dakota (remote); North Carolina (remote); New York (remote); New Mexico (remote); New Jersey (remote); New Hampshire (remote); Nevada (remote); Nebraska (remote); Montana (remote); Missouri (remote); Mississippi (remote); Minnesota (remote); Michigan (remote); Massachusetts (remote); Maryland (remote); Maine (remote); Louisiana (remote); Kentucky (remote); Kansas (remote); Iowa (remote); Indiana (remote); Idaho (remote); Georgia (remote); Florida (remote); Delaware (remote); Connecticut (remote); California (remote); Arkansas (remote); Arizona (remote); Alabama (remote); Washington, D.C. (remote); Wyoming (remote); Wisconsin (remote); West Virginia (remote); Washington (remote); Virginia (remote); Vermont (remote); Texas (remote) Job Category Regulatory Affairs Date posted 06/03/2022
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 role resides within the Global Regulatory Affairs, Advertising and Promotions Group. This group owns the global Advertising and Promotions (Ad Prom) process, and the system that enables the process (Veeva Promomats). This role is responsible for creating the FDA submission package for promotional material in Veeva Promomats, and also for general system administration and configuration for Veeva PromoMats. An ideal candidate will have back-end experience with Ad Prom systems and software's, or have general Information Technology or Systems Administration experience within a life science or other technical environment.
Under general supervision, responsible for Veeva PromoMats, Tableau , and regulatory documents for FDA submission.
Perform Veeva PromoMats system updates (i.e., workflows, configurations, lifecycle management, XML management, spreadsheets, templates, etc.)
Identify areas for improvement/modification
Compile regulatory documents for FDA submission (eCTD experience preferred)
Track of status and progress of regulatory documentation
Review, edit and proofread regulatory documentation
Participate as an active team member of project teams as required
Maintain regulatory files in a format consistent with requirements
Maintain awareness of regulatory requirements
Develop training material and liaise with cross function teams
Understand internal global process (i.e. Advertising and Promotion process)
Bachelor’s degree or country equivalent required
3+ years of pharmaceutical industry experience preferred; 1-2 years of regulatory experience preferred or IT concentration in life sciences, technical/engineering or related field
Understanding of Veeva software (i.e., PromoMats or RIM) design, Zinc software design, or similar system design
Understanding of Tableau software design
Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines
Strong analytical skills, including digital competency
Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including Sharepoint, Power Automate and Excel)
Proofreading and editing skills
Ability to contribute to multiple projects from a regulatory affairs perspective
Ability to multitask and problem solve
Knowledge of regulations for FDA submission preferred
If you are based at our Deerfield, IL facility your employment is conditional upon being fully vaccinated for COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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