Sr. Specialist, Medical Affair

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

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 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 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 up-to-date 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 you'll 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 problem-solving and resolution skills, ability to work effectively with cross-functional teams, and ability to analyze, organize, and react to diverse activities in a c