Job Overview:
Responsible for supporting Quality Control and Compliance activities across Medical Information projects, ensuring the accuracy and quality of deliverables, adherence to regulatory requirements, client agreements, internal SOPs, and service level agreements (SLAs).
Key Responsibilities:
- Perform quality checks of medical enquiry responses received from patients, consumers, healthcare professionals, and other stakeholders through calls, emails, fax, and other channels.
- Review Frequently Asked Questions (FAQs), Standard Response Documents (SRDs), and other Medical Information deliverables for accuracy, consistency, and compliance.
- Ensure proper tracking, maintenance, and documentation of medical enquiries and project records.
- Ensure compliance with applicable regulatory requirements, industry guidelines, client agreements, internal procedures, and quality standards.
- Support Medical Information project setup, database setup, validation, and training activities.
- Identify quality issues, deviations, and compliance gaps, and support corrective actions and continuous process improvement.
- Maintain quality and compliance documentation and support internal and external audits and inspections.
- Author, review, and update SOPs, work instructions, and other relevant departmental documents.
- Coordinate with internal and external stakeholders to ensure compliance with applicable requirements and timely delivery of quality outputs.
- Take ownership of assigned projects and tasks, ensuring effective functioning, adherence to timelines, and consistent quality.
- Monitor departmental workload and escalate personnel, resource, or operational concerns that may affect quality or service delivery.
- Provide line management support, train and mentor assigned personnel, and identify relevant training and development needs.
- Ensure flexibility to work across international time zones, including EST and GMT, as required.
- Perform other responsibilities as assigned by management.
Preferred Qualifications and Skills
- Experience in Medical Information, pharmaceutical Quality Control, Quality Assurance, Compliance, or a related life sciences function.
- Knowledge of medical enquiry management, regulatory requirements, quality standards, SOPs, and documentation practices.
- Strong analytical, communication, organizational, and attention-to-detail skills.
- Ability to manage multiple tasks, coordinate with stakeholders, and meet project deadlines.
