Senior Medical Information Specialist

Soterius, Inc.; Oregon (WI); Hybrid; USD 85,000 - 125,000; Full time

Job summary

Soterius, Inc. is seeking a Senior Medical Information Specialist to support medical information services, handle medical enquiries, and manage projects.

The role requires collaboration with internal and external stakeholders, regulatory compliance, and maintaining high-quality documentation, with night shifts in EST.

Qualifications

• Must be able to interpret medical information and regulatory guidelines.
• Experience coordinating projects and timelines.
• Ability to produce high-quality, accurate documentation.

Responsibilities

• Ensure compliance with client agreements and applicable regulations and guidelines.
• Own assigned projects and ensure adherence to timelines and quality.
• Management of quality, compliance, and documentation across assigned projects.
• Train and mentor personnel, as needed.
• Respond to audits and inspections and represent department.

Skills

Medical information

Project mgmt

Regulatory compliance

Documentation

Stakeholder collaboration

Job description

The Senior Medical Information Specialist will support medical information services by handling medical enquiries, managing assigned projects, ensuring regulatory compliance, and maintaining high-quality documentation. The role involves collaboration with internal and external stakeholders and requires working in eastern time zone (Night Shift).

Key Responsibilities:

• Ensures effective functioning of assigned projects in compliance with client agreements and applicable regulations and guidelines.
• Have ownership of assigned projects and tasks and ensure adherence to timelines and quality.
• Management of quality, compliance, and documentation across assigned projects.
• Manage and monitor the workload of department / function and alert the functional head / designate in the event of concerns or issues regarding personnel management that may affect the quality and functioning of the work.
• Line management for assigned personnel.
• Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulations and guidance.
• Train and mentor personnel, as needed.
• Identify new training and development requirements relevant to the function.
• Respond to / represent department / function during audits and inspections.
• Author and review SOPs and other documents relevant for department/ function.
• Handling medical enquiries received from patients, consumers, health care professionals, and other via calls, emails, fax, and mails. May be required to work as per different time zones (Non-IST, e.g. EST, GMT, etc.).
• Development of frequently asked questions (FAQs), Standard Response Documents (SRDs).
• Tracking and maintenance of medical enquiries.
• Quality check of the medical enquires responses.
• Medical Information project setup, database setup, validation and training
• Other responsibilities as assigned by the Management.