at Baxter Healthcare Corporation in Deerfield, Illinois, United States
Job Description
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Your Role at Baxter
This is where your work saves lives
The Manager, Medical Information will serve as a subject matter expert for the assigned product line/ therapeutic area(s) in Renal Care. The Manager, Medical Information will have clinical knowledge of Baxter products and therapies and is responsible for all aspects of Medical Information support for these products as assigned.
What you'll be doing
Manage Medical Information (MI) inquiries, including escalations. Research, respond, and document inquiries received, in accordance with FDA guidelines for the dissemination of MI.
Provide accurate and timely clinical, medical, and scientific information upon the unsolicited requests of external healthcare professionals and customers, as well as internal Baxter functional areas.
Create and maintain standard response documents, and other correspondences that are necessary to respond to the requests of internal and external customers, within the Medical Information Content Management system.
Assess and present VOC to cross functional stakeholders. Identify market trends, customer needs, and changing clinical practice and communicate back to therapeutic area stakeholders.
Participate in the planning, development, and execution of medical information to support product launches.
Participate in initiatives that improve and streamline current processes within Medical Information to improve medical communication services to internal and external customers.
Maintain current familiarity of published medical literature relating to product lines so that information can be provided to the business unit relating to clinical trends and the potential impact on product lines.
Represent Medical function to review and approve US Advertising and Promotion material (including brochures, sales training material, etc.) ensuring that the medical and/ or scientific information is medically accurate, not misleading, medically relevant, well substantiated with rigorous scientific data, balanced with appropriate risk and benefit information, and is consistent with approved product labeling.
Maintain current knowledge of FDA requirements as related to the Medical review component for US Advertising and Promotion.
Develop/execute internal and external education/training programs with respect to medical/clinical issues within the product line/therapeutic area.
Assist Baxter's regulatory and Quality groups by providing clinical input and support into the evaluation of product complaints and adverse events when requested.
Provide support for medical information booths at conferences.
What you will bring
Bachelors degree
Clinically skilled, licensed Registered Nurse with renal experience.
Minimum 5 years clinical experience.
Experience in Peritoneal Dialysis, Hemodialysis, and/or CRRT areas preferred.
Excellent medical writing and oral communication skills.
Ability to search and summarize medical literature/data accurately and appropriately.
Able to participate in a cross-functional team approach.
Excellent presentation and teaching skills.
Excellent interpersonal skills and a demonstrated ability to manage conflict situations as well as a demonstrated record of responsible actions.
Solid knowledge and ability to apply FDA regulations for medical communications.
Knowledge of computer systems including Windows applications required.
Strong knowledge and / or experience with Baxter products and competitive products is helpful.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This... For full info follow application link.
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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