Medical Affairs Specialist

Baxter International

San Gwann, Malta

The Medical Affairs Specialist will provide clinical expertise across Clinical Nutrition and Pharmacy Tools 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. The Medical Affairs Specialist will be responsible for development and maintenance of the DoseEdge Formulary and Risk Files under the supervision of the medical affairs subject matter expert. 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, or 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 as well as Quality, Regulatory and Patient Safety departments.

Essential Duties and Responsibilities:

Develop and Update the DoseEdge Formulary – Drug and Product.
Provide medical/clinical expertise related to use of DoseEdge, Pharmacy Tools, DoseIQ, and Parenteral Nutrition products including their clinical use and potential misuse to internal cross functional teams.
Lead the medical owned documents and medical review for the DoseEdge Risk File Gap assessment and Update.
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 labelling.
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 Pharmacy Tools and Parenteral Nutrition portfolio.
Ensure compliance of all related clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable).

Qualifications:

Master in Pharmacy or PharmD.
3 years clinical experience in community pharmacy (drug compounding experience).
Knowledge of computer systems including Windows applications required.
Knowledgeable about Baxter products including Baxter Medical Products & Therapies portfolio preferred.
Familiarity with EU and US Pharmacy Regulations, USP (United States Pharmacopeia) 797 and 795, and ISMP (Institute of Safe Medication Practices) 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 meticulous attention to detail.
Ability to apply global regulatory authorities’ regulations and/or guidance.
Ability to manage multiple projects with competing priorities.