
Medical Affairs Specialist
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.
Summary
The Medical Affairs Specialist will provide clinical expertise across product line(s) via development and review of various documents describing the clinical use of the products and the benefit and risk of the products. As a healthcare company Baxter is required to develop and submit various regulatory documents to regulators around the world. This position will develop and review various documents such as annual reports for our products, risk management plans, development plans for new products or changes on existing products and document related to manufacturing and design changes. This person will work with cross functional teams globally, including individuals within Medical Affairs, Clinical Development, Quality, Regulatory, and Patient Safety departments.
Essential Duties and Responsibilities (The incumbent will perform other duties as assigned.)
- Provide medical/clinical expertise related to use of products in the Baxter Pharmaceuticals portfolio and related products including their clinical use and potential mis-use to internal cross functional teams.
- Maintain familiarity with the published medical literature relating to the product lines so that information can be incorporated in various documents created within the organization in compliance with global regulations.
- Possess an understanding and maintain current knowledge of regulatory and quality requirements.
- Develop/review annual documents such as PBRER, PSUR, CER, RMPs, and product labeling.
- Develop and review quality related documents as they pertain to Baxter Pharmaceuticals products.
- Provide clinical support of complaint analyses.
- Assist Baxter’s Regulatory Affairs by providing clinical input into the evaluation and response to MOH queries.
- Develop expert knowledge on Baxter Pharmaceuticals product portfolio.
- Ensure compliance of all related clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable).
- Includes collaborating with medical editors to ensure documents are publication ready across functional teams.
- Summarizing medical information that can be understood by medical as well as non-medical experts.
Qualifications
- Master in Pharmacy, PharmD, or BS Pharm (with appropriate experience)
- 3 years clinical experience (drug compounding experience)
- Knowledge of computer systems including Windows applications required.
- Experience in document compiling such as PSURs, PBRERs, CERs, or Risk Management documentation (i.e. HSHAs)
- Knowledge about products in Baxter Pharmaceuticals portfolio
- Familiarity with US Pharmacy Regulations, USP (United States Pharmacopeia) 797 and 795, ISMP (Institute of Safe Medication Practices) Guidelines, and other clinical practice guidelines preferred.
Education and/or Experience
- Strong communication, writing, analytic and problem-solving skills required.
- Ability to build strong relationships with internal customers.
- Effective interpersonal skills to work with all levels of cross functional Baxter organization and ability to work well with team members.
- Excellent English written and oral communication skills.
- Team-oriented.
- Self-motivated with exceptional follow through.
- Knowledge of current healthcare trends.
- Experience in scientific and/or medical writing.
- Experience in conducting literature searches and the analytical evaluation of scientific data.
- Strong organizational skills and attention to detail.
- Ability to apply global regulatory authorities’ regulations and/or guidance.
- Ability to manage multiple projects with competing priorities.
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.
Dirección

Contenidos relacionado
-
Beneficios para los empleados Nuestras amplias opciones de prestaciones reflejan el valor que otorgamos a nuestros empleados. March 28, 2024
-
Gente de Baxter La gente de Baxter son hombres y mujeres que marcan la diferencia en el trabajo y en sus comunidades. March 28, 2024 Read Time: 5 min. Our Stories - Hub Employee Stories Article
-
Our Kidney Co Separation We have finalized our separation of our Kidney Care Global Business Segment. May 03, 2024 Related Content - SR_JD
-
Áreas profesionales Explora nuestras distintas áreas profesionales y descubre el que mejor se adapta a tus talentos y objetivos profesionales. March 05, 2024 5 Minute Read Related Content - SR_JD Our Stories - Hub Related Content - Culture Employee Stories Career Advice Article
-
October 24, 2024
-
October 24, 2024
-
Cómo postularse Aprende consejos para prepararte mejor para el proceso de postulación. March 05, 2024 Read Time: 5 min. Related Content - SR_JD Featured Stories - Hub Our Stories - Hub Related Content - Culture Career Advice Article
-
Our Culture At Baxter, we intersect products with healthcare professionals and caregivers. Each employee finds support hroughout their journey, fostering career development and prioritizing well-being through programs, resource groups, and events. Our collaborative environment celebrates diversity and encourages growth. March 05, 2024 Read Time: 5 min. Our Stories - Hub Employee Stories Culture Employee Wellness Article
-
Diversity, Equity & Inclusion We prioritize relationships and take time to get to know one another here at Baxter. Our commitment to driving diversity, equity, and inclusion is at the forefront of everything we do. We foster cultural awareness and community through programs, and employee resource groups, that celebrate and support our differences. March 05, 2024 Read Time: 5 min. Our Stories - Hub Corporate Responsibility Business Resource Groups DE&I Article
-
Manufacturing in Aibonito, PR The Aibonito site at Baxter is a state-of-the-art manufacturing facility in Puerto Rico, dedicated to producing high-quality intravenous solutions and pharmaceuticals. The site employs cutting-edge technology and rigorous quality control processes to ensure the delivery of life-saving products to patients worldwide. July 09, 2024 Read Time: 5 min. Our Stories - Hub Location Highlights Article
-
Global Business Solutions Global Business Services (GBS) is the central hub of support for Baxter Healthcare's internal operations, offering a wide range of services to streamline business functions and improve efficiency. GBS encompasses Finance, IT, Human Resources, Procurement, and Supply Chain Management, ensuring seamless operations and maintaining Baxter's commitment to delivering quality products and services to patients worldwide. March 05, 2024 Read Time: 5 min. Our Stories - Hub Employee Stories Article
Únete a nuestra comunidad de talentos
Agradecemos tu interés en una carrera en Baxter y nos gustaría conocerte. Unirte a nuestra Comunidad de talentos es una excelente manera de mantenerse conectado, conocer más a Baxter y ayudar a nuestros reclutadores a encontrarte en caso de que haya una oportunidad que coincida con tu formación, tus habilidades y tus intereses.