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.
Your role at Baxter:
Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. At Baxter, our mission is to save and sustain lives. Our global businesses segment, Healthcare Systems and Technology (HST) is comprised of: Front Line Care (FLC), Patient Support Systems (PSS), Global Surgical Solutions (GSS), Connected Care Group, and are focused on transformative innovation to deliver smarter, more personalized care for patients and providers. Every day our mission to save and sustain lives is at the forefront as we strive to meet our goal of top-quartile performance. Our objective is to accelerate growth by expanding Baxter’s impact across the healthcare spectrum supported by the evolution of our new product pipeline.
The Senior Specialist serves as a global medical affairs team member supporting New Product Development (NPD) and Sustaining activities for assigned division product portfolio. This position will also support Subject Matter Experts (SME) and Clinical Evaluators for relevant medical device and regulated healthcare software regulatory requirements when applicable [e.g. EU Medical Device Directive (MDD), EU Medical Device Regulation (MDR), etc.]. In addition, provide additional relevant support as needed. Critical to this role is global and regional clinical knowledge of medical devices, environments of care and data use as well as the ability to offer guidance for product development support.
What you'll be doing:
Serve as the medical/ clinical subject matter expert to both internal and external customers for sustaining and some product development efforts.
Develops and delivers medical/clinical input into relevant medical device technical documents (e.g. user manuals, operator manuals, etc.) supporting product launch and sustaining activities.
Develops and delivers medical/clinical input into relevant medical device training documents (e.g. training decks, in-service scripts, eLearning tools, etc.) supporting product launch and sustaining activities.
Supports Clinical SMEs with relevant medical writing expertise for evidence generation (e.g. white papers, clinical studies, publication plan, etc.).
Contributes to development and review of risk documentation, early and late phase testing.
Participates in development of claims matrix, identification in gaps and development of evidence generation plan in collaboration with R&D, Marketing, and Medical Affairs organizations.
Supports other miscellaneous projects, based on skill sets and credentials, as needed.
Develops and maintains knowledge base for related Baxter Care Communication products.
As appropriate for the products in the Connected Care Group portfolios…
Provides medical writing support for relevant EU MDD/MDR deliverables (i.e. CEP, CER, PMCF, SSCP)
Collaborates with Deliverable Program Managers (DPM) for coordination and execution of EU MDD/MDR deliverables
Participates, as needed, in relevant EU MDD/MDR Core Team meetings
Supports process and logistics planning for EU MDD/MDR activities
Supports Clinical SMEs and Clinical Evaluators for relevant clinical literature searches related to EU MDD/MDR
Supports legal, regulatory, and quality requirements related to R&D and product lifecycle management.
Maintains compliance with current standard operating procedures.
Assumes other duties and responsibilities as assigned by manager/supervisor.
Clinical core competency for related products.
What you'll bring:
Strong problem solving and resolution skills with ability to influence and effectively work with cross-functional teams
Sound scientific clinical approach to medical writing based on previous experience, technical writing, and ability to analyze information fostering clinical credibility
Advanced interpersonal and communication skills with demonstrated ability to manage conflict situations
Self-motivated with exceptional follow through, effective time management skills, and ability to multitask
Ability to analyze, organize, and react to diverse activities in a changing environment often with time constraints
Ability to work collaboratively and inclusively across diverse cultures
Effective and competent presentation and educating skills
Ability to work across multiple time zones required
New product development and product lifecycle management experience preferred
EDUCATION & EXPERIENCES:
Degree in nursing, nursing informatics, or other clinical discipline with relevant experience required
Advanced degree preferred
3+ years of acute adult medical surgical, intensive care or related clinical experience required; industry experience strongly preferred
Specialty certification preferred with preference to digital health, nursing informatics, nursing workflow and communications, or related specialty preferred
Active license in a U.S. state or territory in good standing required with clinical expertise
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 policy provides the benefits of connecting and collaborating in-person in support of our Mission.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 to $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
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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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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
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 Recruitment Fraud Notice.
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