Medical Information Specialist II

About the role

The Medical Information Specialist II provides virtual and telephone support to healthcare professionals, patients and other stakeholders, delivering accurate drug and medical device information while ensuring compliance with regulatory standards.

Key responsibilities

• Maintain high quality and productivity across client programs, following scripts and guidelines.
• Identify, address and document information requests, adverse events, product quality complaints and other reportable items in line with client and regulatory requirements.
• Conduct compliance calls for volunteers in clinical research trials and enroll participants in educational seminars.
• Provide patient support for those enrolled in Patient Support Programs and manage demographic and disposition data for product, sample and literature fulfillment.
• Capture program‑specific information accurately in designated databases.
• Communicate empathetically, explaining medical terminology in clear language.
• Support administrative tasks as needed to meet operational demands.
• Adhere to company policies, SOPs and compliance requirements, safeguarding patient privacy under HIPAA and South African regulations.

Required profile

• Registered Professional Nurse in good standing with the South African Nursing Council (SANC) or equivalent qualification.
• Strong knowledge of FDA regulations, pharmacovigilance requirements and HIPAA privacy and security rules.
• Ability to work remotely with a secure home office, reliable internet and business continuity arrangements.
• Excellent organizational skills and the capacity to manage multiple priorities simultaneously.

Required skills

• FDA regulations
• Pharmacovigilance
• HIPAA compliance