Medical Affairs Specialist

Our client, a Global Manufacturer and Supplier of Medical Devices, is recruiting for a Medical Affairs Specialist to join their team in Malta. Reporting to the Medical Affairs Specialist, your duties will include;

• Provide medical/clinical expertise related to use of products in the company's 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 labelling.
• Develop and review quality related documents as they pertain to the company's products.
• Provide clinical support of complaint analyses.
• Assist the company's Regulatory Affairs by providing clinical input into the evaluation and response to MOH queries.
• Develop expert knowledge on 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.

• 3 years clinical / Medical experience is desired
• 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
• Very strong communication skills including high proficiency in Written and Spoken English
• Self-starter and able to work independently when required

• Master in Pharmacy, PharmD, or BS Pharm (with appropriate experience)

• Flexible / Hybrid working conditions