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Medical Affairs Specialist

Malta, San Ġwann 32000.00 EUR / Year · Job Posted April 11, 2026

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Job Description

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. 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.

Job Responsibility

  • Provide medical/clinical expertise related to use of products in the Baxter IV Access and administration pumps portfolio and related products
  • Maintain familiarity with the published medical literature relating to the product lines
  • 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
  • Collaborate with medical editors to ensure documents are publication ready across functional teams

Requirements

  • Bachelor's Degree or Master's degree in Nursing
  • Masters degree or Doctorate Degree in Pharmacy, or Medical Doctor
  • 3 to 5 years clinical experience in renal/dialysis, surgery, nutrition, or critical care
  • Knowledge of computer systems including Windows applications required
  • 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

Nice to have

  • Knowledge about products in Baxter Clinical Nutrition and Medication Delivery Portfolio
  • Familiarity with Infusion Therapy Guidelines and EU MDD/MDR

What we offer

  • competitive benefits
  • discretionary bonuses
  • long-term incentive

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