Manager, Global Regulatory Affairs - Advertising and Promotions (Remote)Req # JR - 061922 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); Utah (remote); Texas (remote) Job Category Regulatory Affairs Date posted 03/09/2022
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.
Under general supervision responsible for leading the Regulatory (Advertising & Promotion) systems specialist/business administration team. This individual will lead the coordination, preparation, and at times implementation of system configuration changes, system training material, documents/packages for regulatory submissions, gather and analyze metrics related to internal processes (advertising & promotion), and review and evaluate technical data and reports in support of Baxter’s products and processes.
Lead RA Business Admin group with administrative responsibilities related to management of internal global process and system (ie. Advertising and promotion process/PromoMats System (Veeva Vault Platform))
Develop training material and liaise with cross functional teams
Review, edit and proofread regulatory and commercial-driven system documentation
Lead in preparation and review of SOP’s and other departmental documents
Lead to compile regulatory documents for FDA submission (eCTD experience preferred)
Participate as an active team member of project teams as required
Compile and prepare responses to regulatory authorities’ questions
Maintain regulatory files in a format consistent with requirements
Maintain awareness of regulatory requirements
Bachelor’s degree or country equivalent required; at least >7 years of pharmaceutical industry experience
3+ years of regulatory experience preferred; concentration in life sciences, technical/engineering or related field preferred
Experience with Veeva Vault software (ie. Promomats) specifically as it relates to management of promotional material review and approval
Excellent written and verbal communication skills, ability to organize, prioritize and meet deadlines
Strong analytical skills, including digital competency
Strong knowledge of regulations for US FDA submission of promotional material
Strong technical systems skills (e.g. word processing, excel spreadsheets, databases, online research), including extensive experience working within the back-end of systems and driving configurations stemming from business needs
Proofreading and editing skills
Ability to contribute to multiple projects from a regulatory affairs or commercial perspective
Ability to multitask and problem solve complex matters
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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