Team Lead - Medical Information

Soterius, Inc.; Oregon; Hybrid; USD 110,000 - 160,000; Full time

Job summary

Soterius, Inc. is seeking a proactive Medical Information and Compliance Manager to oversee project compliance with client agreements and regulatory guidelines. You will own assigned projects, manage timelines, and ensure quality, documentation, and QA across the function.

You will line-manage staff, train and mentor, coordinate with internal and external stakeholders, respond to audits, and develop SOPs and standard responses. Some duties may require work across time zones.

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 mail. 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.

Job description

• 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 mail. 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.