Sr. Specialist, Medical Affairs

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.

The Senior Medical Affairs Specialist (MAS) serves as a global medical affairs team member supporting 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 (MOD), EU Medical Device Regulation (MOR), etc.]. In addition, provide 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. This involves participation in creating and reviewing user needs, design input and risk documents, planning and participating in formative and summative studies, and design reviews. The MAS may also partner with Clinical Ops to plan and conduct studies in support of product claims and support commercial activities. The MAS will be reviewing and approving medical content for marketing, educational purposes, and product development while monitoring emerging trends and regulation in the healthcare industry.

The position reports to: Associate Manager, Medical Affairs

ESSENTIAL DUTIES and RESPONSIBILITIES:

• 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 sustaining activities.
• Develops and delivers medical/clinical input into relevant medical device training documents (e.g. training decks, in-service scripts, e-learning tools, etc.) supporting sustaining activities.
• Contributes to development and review of risk documentation.
• Participates in development of claims matrix, identification in gaps and development of evidence generation plan in collaboration with Clinical, 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.
• Provides Medical SME support for relevant EU MDD/MDR clinical and post-market surveillance deliverables (as appropriate for products in Front Line Care portfolio)

KEY QUALIFICATIONS:

• 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
• Product development and lifecycle management experience preferred

EDUCATION & EXPERIENCES:

• Degree in nursing, nursing informatics, or other clinical discipline with relevant experience in product portfolio required
• Advanced degree preferred
• 5 years of acute adult primary care, medical surgical, or related clinical experience required; industry experience strongly preferred
• Active license within territory in good standing required with clinical expertises.

OTHER REQUIREMENTS:

• Travel required domestic and internationally up to 20%
• Located in Malta

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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