Medical Excellence Officer at Sanofi

Job description

Having recently evolved to re-position itself for the future in a vibrant emerging market, our company is currently looking for a Medical Excellence Officer. This is an exceptional opportunity to contribute to the resounding success of a highly patient-centric organisation that continually explores opportunities to enhance life and respond to the potential healthcare needs of people in Africa.

The Medical Excellence Officer role will report to the Medical Director for East African Hub and Nigeria and Ghana affliate. The scope of operations include Kenya, Ethiopia, Uganda andTanzania. The objectives of the position are as follows:

Ensure compliance with corporate and regulatory obligations regarding the safety of all the organization’s products. Partners the commercial organization through integrated medical and scientific support and provide the scientific competence needed to ensure that the organization’s products reach their full commercial potential and respect the ethics.

Provide to the affiliate the expertise in the field of medical excellence, clinical operations and coordinate the various acitivities.

Support the implementation and maintenance of an appropriate Affiliate Quality Systems In hub in compliance with the organization’s Quality Policy concerning all activities related to the clinical investigation, distribution and marketing of all products developed and/or marketed in the country by the organization or through partnership agreement.

Key Accountabilities

Medical Excellence

• Ensure development & updating local medical and regulatory affairs SOPs
• Review of the SOPs developed by the Clinical Operation / DRA.
• Ensure that the Medical & Regulatory Staff are trained on the relevant SOPs.
• Training for the newly hired Medical staff on the relevant SOPs.
• Manage the medical quality function through auditing various medical activities to ensure the implementation of SOPs.
• Perform ad hoc audits when needed.
• Follow up on the corrective action plan for the recommendation of audits.
• Responsible for the training of the partners of the medical department on the relevant SOPs e.g. Promotional Materials approval, Good promotional practices, etc.
• Implement and coordinate the approval process for Promotional materials within the affiliate
• Ensure that Patient Support Programs (PSPs) are complying with SOPs and guidelines.
• Coordinate and elaborate the ITC medical dashboard report.

Clinical Operations

• Ensure that all SOPs are implemented and Good Clinical Practice are applied.
• Cross fertilized the clinical study through the 2 affiliates in order to have common protocols and validate the synopsis.
• Follow-up the clinical studies and fill Clear and Club-net data base accordingly.
• Ensure that Clinical Study Reports (CSRs) are done as well as publications.