Sr. Specialist, Global Medical Affairs (Hst)

Baxter

3+ years

$104,000 to $143,000

Raleigh

10 Nov. 23, 2024

Job Description

Job Type: Full Time Education: Degree in nursing, nursing informatics, or other clinical discipline Skills:

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.

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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 business segment, Healthcare Systems and Technology (HST), is comprised of Front Line Care (FLC), Patient Support Systems (PSS), Global Surgical Solutions (GSS), and the Connected Care Group, all focused on transformative innovation to deliver smarter, more personalized care for patients and providers. Every day, our mission to save and sustain lives drives us 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 the 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.). Additionally, this role provides 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.

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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.
- Develop and deliver medical/clinical input into relevant medical device technical documents (e.g., user manuals, operator manuals) supporting product launch and sustaining activities.
- Develop and deliver medical/clinical input into relevant medical device training documents (e.g., training decks, in-service scripts, eLearning tools) supporting product launch and sustaining activities.
- Support Clinical SMEs with relevant medical writing expertise for evidence generation (e.g., white papers, clinical studies, publication plans).
- Contribute to the development and review of risk documentation, early and late-phase testing.
- Participate in the development of claims matrixes, identify gaps, and collaborate with R&D, Marketing, and Medical Affairs organizations to create evidence generation plans.
- Support other miscellaneous projects, based on skill sets and credentials, as needed.
- Develop and maintain a knowledge base for related Baxter Care Communication products.

For the products in the Connected Care Group portfolios:
- Provide medical writing support for relevant EU MDD/MDR deliverables (e.g., CEP, CER, PMCF, SSCP).
- Collaborate with Deliverable Program Managers (DPM) for coordination and execution of EU MDD/MDR deliverables.
- Participate in relevant EU MDD/MDR Core Team meetings as needed.
- Support process and logistics planning for EU MDD/MDR activities.
- Assist Clinical SMEs and Clinical Evaluators with clinical literature searches related to EU MDD/MDR.
- Ensure compliance with legal, regulatory, and quality requirements related to R&D and product lifecycle management.
- Maintain adherence to current standard operating procedures.
- Assume other duties and responsibilities as assigned by the manager/supervisor.

What you'll bring:

- Strong problem-solving and resolution skills with the ability to influence and effectively work with cross-functional teams.
- A sound scientific clinical approach to medical writing, supported by previous experience, technical writing, and information analysis to foster clinical credibility.
- Advanced interpersonal and communication skills with demonstrated conflict management abilities.
- Self-motivation with exceptional follow-through, effective time management skills, and multitasking ability.
- Capability to analyze, organize, and adapt to diverse activities in a changing environment, often under time constraints.
- Ability to work collaboratively and inclusively across diverse cultures.
- Effective and competent presentation and educational skills.
- Ability to work across multiple time zones.
- Preferred new product development and product lifecycle management experience.

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Education & Experiences:

- Degree in nursing, nursing informatics, or another 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 an emphasis on digital health, nursing informatics, nursing workflow and communications, or related specialties.
- Active license in a U.S. state or territory in good standing required with clinical expertise.
- Domestic and international travel required up to 50%.

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Baxter is committed to supporting the needs of flexibility in the workplace. We do so through our flexible workplace policy, which includes a minimum of three 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, 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.

#LI-MS1

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.

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.

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Sr. Specialist, Global Medical Affairs (Hst)

Job Description

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