Manager, Medical Information

What you'll be doing

• Lead the management of Medical Information (MI) inquiries, including escalations, by researching, preparing, and documenting responses in alignment with FDA regulations governing MI dissemination.
• Provide timely, accurate, and balanced clinical, medical, and scientific information to external healthcare professionals and internal Vantive partners.
• Develop, update, and maintain standard response documents and other communication materials within the Medical Information content management system.
• Gather and communicate Voice of Customer (VOC) insights to cross functional stakeholders, identifying trends in market needs, customer expectations, and evolving clinical practices.
• Collaborate on the planning, development, and implementation of Medical Information deliverables that support new product launches and ongoing product lifecycle needs.
• Contribute to process improvement initiatives designed to enhance efficiency, quality, and service within Medical Information operations.
• Maintain up to date knowledge of the scientific literature and clinical developments relevant to assigned product lines and associated therapeutic areas and translate insights into meaningful business support.
• Serve as a Medical reviewer for U.S. Advertising and Promotion materials, ensuring scientific accuracy, fair balance, adequate substantiation, and alignment with product labeling and regulatory standards.
• Stay current on FDA requirements related to medical review aspects of promotional materials.
• Develop and deliver internal and external education and training programs addressing clinical and medical topics within defined therapeutic areas.
• Provide clinical expertise to Regulatory and Quality teams by contributing to the evaluation of product complaints and adverse events as needed.
• Support Medical Information and Medical Affairs activities at scientific conferences, including booth coverage and clinician engagement.
• Perform other duties as assigned by the Senior Manager, Americas Medical Information.

What you'll bring

• Licensed Registered Nurse with strong clinical expertise.
• Clinical experience in Peritoneal Dialysis, Hemodialysis, and/or Continuous Renal Replacement Therapy (CRRT) preferred.
• Minimum of 10 years of clinical experience.
• Strong proficiency with Windows based computer systems.
• Knowledge of Vantive products and competitor products desirable.
• Prior Medical Information or Medical Affairs experience strongly preferred.
• Excellent medical writing and verbal communication skills.
• Strong ability to search, evaluate, and synthesize medical literature and scientific data.
• Effective collaborator skilled in cross functional teamwork.
• Strong presentation and teaching capabilities.
• Exceptional interpersonal skills with demonstrated ability to manage conflict and exercise sound judgment.
• Self-motivated with strong follow-through and attention to detail.
• Solid understanding of FDA regulations governing medical communications.