Job Brief:

As a Regional Medical Manager, you are accountable for developing a Medical and Scientific Affairs team in the business area of responsibility. This Role contributes to the collective medical leadership of the company product portfolio (excluding oncology portfolio) by ensuring it adheres to the highest scientific, regulatory, and ethical standards. This role is responsible for the management of MSL team in the territory of responsibilities.

The role provides strategic direction and leadership to the regional M&SA activities. It develops and starts the implementation of strategies and tactics developed by the Medical & Scientific Affairs department in Dubai to increase medical awareness and our products' clinical value by focusing on development of educational activities, partnerships with professionals and their associations for respective market and disease segments.

Major Accountabilities

• Identify unmet medical needs at medical and scientific customer regional sites, and address questions/concerns from the scientific communities.
• Identify key knowledge gaps in medical and scientific field and propose appropriate action plan.
• Lead implementation of relevant Scientific Affairs projects to the assigned region.
• Develop Medical Strategy & Tactics in selected countries: and develop clinical messages for the product line to support the countries.
• Implement tools to monitor medical activities of the department.
• Lead the field Scientific Affairs team (MSL) to achieve the plans.
• Identify and build relationships with National, Regional, or International KOLs and Thought Leaders.
• Contribute to and support the clear articulation of a compelling brand strategy for the area of responsibility across marketing and sales functions.
• Develop and ensure all medical and product information is provided in compliance with Global SOPs and local regulatory requirements and that all data used in the provision of medical information are accurate and meet the needs of internal and external customers.
• Assist in the organization and support of key external National and Regional scientific events e.g., satellite symposia etc.
• Deliver lectures on scientific, clinical, and technical topics spontaneously requested, and ensuring appropriate approval in relevant systems.
• Attending appropriate scientific congresses to interact with HCPs, develop knowledge in relevant therapy areas and to produce congress summaries for dissemination to internal & external stockholders.
• Support the dissemination of product and disease area knowledge across the company in accordance with business priorities.
• Undertake regular communication of best practice and facilitation of knowledge sharing cross functionally and across geographies.
• Undertake slide-deck development and internal training initiatives in coherence with the Medical Manager-Information & Education.
• Gather and report competitive intelligence information from his/her region.
• Responsible for setting up and organizing Scientific Advisory Boards to collect input on disease areas, treatment algorithms, clinical data, and/or protocol design, and audience educational needs.
• Support the Access Strategy and provide data and advice to support the creation of a dossier of health economic data information for market access applications.
• Provide field-based medical support to the Company's clinical research programs as required.
• Contribute to effective and efficient delivery of IIR and non-interventional studies through all phases start-up, conduct and close) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.
• Capable to develop medically sound, feasible, study protocol, CRF, budget and site training material.
• Capable to assess IIR synopsis and grant management that enhance product knowledge.
• Ensure optimal investigators selection by a constructive dialogue between medical and clinical operations.
• Ensure all local clinical trials and contracts are appropriately developed; executed within agreed timelines and budget; in accordance with Directives, SOPs, quality standards, and regulatory requirements.
• Provide direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work.
• Identifies and contributes to areas of best practice and process improvement.
• Being familiar with applicable Local/International regulations related to Pharmacovigilance and EU GVP guidelines.
• Carrying out duties according to relevant SOPs/Working Instructions/Policies as well as to applicable regulations and guidelines, with care to the quality of the work.
• Performing the Triage of all safety information and medical reviewing of all ICSRs, coming from any source, following the current procedures.
• Duly management of all documents/information regarding Pharmacovigilance to keep completeness, traceability, and confidentiality up to the transfer to the Archive.
• Supporting the LDSUM in writing procedures related to activities performed at local level.
• Other duties as necessary at the proper scientific and technical level.
• Comply with the data integrity policy and commitment.
• Monitoring and analyzing the processes and ensuring that the necessary actions are taken for improvement.
• Maintaining, backing up and archiving (or ensuring that they are made) all records under her/his responsibility as determined and destroying the records under his/her responsibility as determined when the retention period expires.
• Fulfilling and implementing responsibilities mentioned in all procedures of the company.
• The process managed in accordance with Company Procedures; s/he is responsible for ensuring that the activities of the inputs and outputs are correct, the resources are sufficient, the process is monitored, the records are kept, the performance is measured and, when necessary, reporting on these issues.

Job Requirements

• Education Level: Bachelor's Degree Medicine or pharmacy with master’s or PhD degree from a globally recognized institution.
• Education Faculty/ Department: MD, Pharma or PharmaD
• At least 5+ years of experience in pharmaceutical industry as Medical Manager and experience in working with senior business leaders, clinicians, and regulatory authorities, with at least 2 years’ experience in subordinate management with and/or without authority.
• Scientific expertise in Medical Affairs activities and relevant therapeutic areas
• Familiar with the medical environment and healthcare system in English Africa
• Experienced in developing and coaching colleagues.
• Fluent written and spoken English, French would be a plus.