Sr. Specialist, Medical Affair

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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters 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 progressive 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 topquartile performance. Our objective is to accelerate growth by expanding Baxters 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 youll be doing

• Serve as the medical/clinical resource for both internal and external customers for sustaining and product development efforts.
• Develop and deliver medical/clinical input for technical and training documents claims matrix risk documentation and EU MDD/MDR results.
• Collaborate with relevant teams including Clinical SMEs R&D Marketing and Medical Affairs for evidence generation clinical literature searches and compliance with regulations and standard operating procedures.
• Participate in relevant EU MDD/MDR Core Team meetings process and logistics planning and support Clinical Evaluators as needed.
• Maintain uptodate knowledge base for related Baxter Care Communication products and assume other duties and responsibilities as assigned by manager/supervisor.
• Demonstrate clinical core proficiency for related products.
• Contribute to development and review of risk documentation early and late phase testing and participate in development of claims matrix identification in gaps and development of evidence generation plan in collaboration with R&D Marketing and Medical Affairs organizations.
• Provide medical writing support for relevant EU MDD/MDR deliverables (i.e. CEP CER PMCF SSCP) and collaborate with Deliverable Program Managers (DPM) for coordination and execution of EU MDD/MDR deliverables.
• Supports Clinical SMEs with relevant medical writing expertise for evidence generation (e.g. white papers clinical studies publication plan etc.).
• Supports other miscellaneous projects based on skills and credentials as needed.
• Supports legal regulatory and quality requirements related to R&D and product lifecycle management.

What youll bring

• Degree in nursing nursing informatics or other clinical subject area with relevant experience required
• 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
• Travel required domestic and internationally up to 50%
• Strong problemsolving and resolution skills ability to work effectively with crossfunctional teams and ability to analyze organize and react to diverse activities in a changing environment often with time constraints
• Sound scientific clinical approach to medical writing based on technical writing information analysis and clinical credibility
• Selfmotivated with exceptional followthrough effective time management and multitasking abilities
• Advanced interpersonal and communication skills with demonstrated ability to manage conflict situations and work collaboratively across diverse cultures.

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.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating inperson in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion Baxter may decide to adjust suspend or discontinue as business needs change.

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 $104000$143000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on upon location skills and expertise experience and other relevant factors. This position may also be eligible for discretionary bonuses. 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.

US Benefits at Baxter (except for Puerto Rico)

This is where your wellbeing matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident shortterm and longterm disability and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount and the 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching. We also offer Flexible Spending Accounts educational assistance programs and timeoff benefits such as paid holidays paid time off ranging from 20 to 35 days based on length of service family and medical leaves of absence and paid parental leave. Additional benefits include commuting benefits the Employee Discount Program the Employee Assistance Program (EAP) and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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.