Medical Information Specialist/Manager/Senior Manager
4-12
Remote
Full-Time
About the Role
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 the 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 guidances.
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 others 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 enquiries responses.
Medical Information project setup, database setup, validation and training.
Other responsibilities as assigned by the Management.
Qualifications
Required:
4–12 years of relevant experience working in medical information function.
Strong communication and time-management skills.
Awareness of global regulatory, pharmacovigilance, medical affairs, and medical information environment.