JOB:
Job Purpose
The Medical Coordinator will support the Medical Department through medical information query management, patient program support, tracking of local and Multi-Country Organization (MCO) medical operating expenses (OPEX), the execution and tracking of the training curriculum for the department, support and uphold a high standard of integrity across all medical activities by ensuring SOP compliance, and ensuring audit readiness.
Key Responsibilities:
Compliance and Audit Readiness
- Ensure the highest standards of compliance and audit readiness within the Medical Department.
- Collaborate with Quality and Ethics & Business Integrity (EBI) teams to ensure and monitor compliance.
- Update and track the expiry of Standard Operating Procedures (SOPs) relevant to the department, under the direction of Quality.
Training and Curriculum Management
- Coordinate and execute the training curriculum for the Medical team, ensuring completion of all required training relevant to local medical functions.
- Establish, track, and maintain training records for all department members, ensuring timely completion and compliance.
- Organize and manage the training record repository for easy access and audit readiness.
Patient Program Support
- Provide operational support for patient programs within the Medical Department, ensuring program activities align with MCO and GxP requirements.
- Track and report on patient program activities to maintain regulatory and ethical standards.
- Coordinate with relevant stakeholders to ensure the successful implementation of patient programs.
Engagements and Compliance with Scientific External Experts (SEEs)
- Monitor SEE engagements to ensure adherence to engagement quantity and honoraria thresholds.
- Implement and monitor compliance with Fair Market Value (FMV) guidelines for SEEs, patients, and patient advocacy groups.
- Conduct live monitoring of a selection of events each quarter to ensure compliance during medico-marketing activities.
1CRM Administration and Event Initiation
- Serve as a 1CRM event initiator for the medical department, ensuring accurate setup and compliance with internal policies.
- Support and train medical department users as needed.
- Ensure team members are informed of system updates and support process simplification.
- Log ‘interactions’ and ‘insights’ on behalf of the medical team and execute ‘free text monitoring’ as per global and MCO monitoring compliance standards.
Medical Information Management
- Manage and track the Medical Information mailbox and handle all inquiries, including telephonic inquiries, during business hours, within designated timelines.
- Ensure compliance with Medical Information SOPs, providing training for relevant personnel.
- Conduct quality checks on automatic email responses, phone routing, and voicemail availability for audit readiness.
- Conduct literature searches to support evidence-based responses, ensuring compliance with Good Scientific Information Practices.
- Ensure all responses adhere to the Protection of Personal Information Act (POPI) and avoid providing medical advice.
- Monitor and provide monthly reports on Medical Information Management performance and query trends.
Sponsorships and Contributions to Healthcare Organizations
- Review sponsorship and contribution requests to ensure compliance with internal policies.
- Manage internal processing of documentation and submit requests to relevant stakeholders.
- Reconcile sponsorships documentation and contributions to ensure accuracy and accountability.
- Archive all documentation related to sponsorships and contributions within relevant tools or platforms, including all reconciliations, proof of payment, to maintain comprehensive records for audit and compliance purposes.
Local and MCO Medical OPEX Tracking
- Monitor and track local and Africa Multi-Country Organization (MCO) medical operating expenses (OPEX) to ensure alignment with budget forecasts.
- Provide regular updates on OPEX status to relevant stakeholders and maintain accurate records for financial reporting and audit purposes.
- Monitor and archive proof of payment to Scientific External Experts (SEEs) to ensure compliance and transparency.
Administrative Support
- Support the Medical Head with high-level administrative tasks, including scheduling meetings, preparing reports, and managing key deliverables.
- Champion the implementation and optimization of medical systems, tools, and processes, ensuring alignment with local and global standards.
- Act as a key point of contact for troubleshooting, training, and improving system use among medical staff.
- Provide project coordination and leadership, including planning, timeline management, stakeholder engagement, and tracking progress for key medical initiatives.
- Manage contracts, vendor coordination, travel and expense processing related to medical projects and events.
Team Structure and Development Support
- Ensure that the Medical team’s organograms and job descriptions are kept up-to-date, using the latest templates.
- Archive and maintain records of organograms and job descriptions to ensure accessibility and audit readiness.
- Ensure all team members have Individual Development Plans (IDPs) in place, though not responsible for the content of these plans.
ABOUT YOU:
- Master’s degree in a scientific discipline, Pharmacist degree, or higher qualification.
- Experience in medical administration or compliance within a pharmaceutical or healthcare environment is an advantage.
- Skills :
- Scientific writing experience.
- Strong proficiency in English (reading, writing, and comprehension).
- Proficient in MS Office (Outlook, Word, Excel, PowerPoint) and quick to adopt digital platforms.
- Excellent organizational skills and attention to detail.
- Ability to work both independently and collaboratively in a cross-functional environment.
Core Competencies
- Strong Scientific Background : Demonstrates the ability to analyze, interpret, and apply scientific learnings to projects and decision-making processes effectively.
- Project Management: Strong skills in planning, coordinating, and executing projects, with the ability to manage timelines, resources, and deliverables.
- System and Process Orientation: Proficiency in navigating and championing digital tools and platforms, ensuring seamless adoption and integration.
- Integrity and Compliance : Uphold the company’s ethical standards and commitment to compliance.
- Communication Skills : Clear, professional communication skills, with the ability to train and support colleagues effectively.
- Problem-Solving : Proactive in identifying and addressing issues within medical processes.
- Adaptability : Ability to manage multiple tasks and adapt to evolving systems and regulations.
Additional Information
- This role requires a meticulous approach, a strong sense of responsibility, and confidentiality in handling sensitive information.
- Occasional travel may be required for training sessions or conferences.
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