Medical Affairs Specialist

Baxter International

San Ġwann, Malta

he 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.

What you'll be doing:

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.

What you'll bring:

Master in Pharmacy, PharmD, or BS Pharm
- 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.
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.