Medical Affairs Specialist

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

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 changes on existing products and documents 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:

• Provide medical/clinical expertise related to use of products in the Baxter IV Access and administration pumps portfolio and related products including their clinical use and potential misuse 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 PBRERs, PSURs, CERs, 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 Clinical Nutrition and Medication Delivery 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.

Education and/or Experience:

• Bachelor's Degree or Master's degree in Nursing, Masters degree or Doctorate Degree in Pharmacy, or Medical Doctor.
• 3to 5 years clinical experience in renal/dialysis, surgery, nutrition, or critical care.
• Knowledge of computer systems including Windows applications required.
• Knowledge about products in Baxter Clinical Nutrition and Medication Delivery Portfolio preferred.
• Familiarity with Infusion Therapy Guidelines and EU MDD/MDR is preferred.

Qualifications:

• 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 meticulous attention to detail.
• Ability to apply global regulatory authorities’ regulations and/or guidance.
• Ability to manage multiple projects with competing priorities.

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 minimum salary for this position is €32,000.00 ​annually. Your initial pay could be at the minimum or higher based on skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. 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.

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.

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.