Ayman Mashaly

· Regional Procedural documents management

• Single point of contact for reviewing Global SOPs and assess applicability across EMEA .
• Collaborate with appropriate stakeholders for the implementation of SOPs related to Medical Affairs activities and its documentation in ESO Implementation Memo's/Impact Assessment Forms and Deviation Memos.
• Issue Regional Implementation Documents where necessary .
• Collaborate with Country Medical Directors CMDs for Local implantation of Procedural documents and assess the need for Local Work Instructions WI or Local implementation documents

· EMEA PV related activities .

• Responsible for EMEA pharmacovigilance master file PSMF preparation and submission
• Monitoring EMEA end to end process of Risk minimization measure from Preparation to distribution and retiring for established products and new launches

·Creating JCI marketing compliance reports covering EU countries , UK and China by evaluate cases of marketing compliance across 34 Countries

· ensure Local Operating Companies readiness for Internal Audits and external Inspections.

· Regional Evidence generation Systems Superuser ensure correct access for users and work with global teams on systems improvements to ensure EMEA compliance

.Leading the regional team of Medical Affairs Compliance Leads MACLs from each cluster

• High level scientific communication on peer-to-peer bases with top leading specialists in GCC in the field of Pulmonary, Cardiology, Rheumatology and Rare Disease
• Lead and support Data generation projects across GCC
• Building comprehensive medical education plan matching company global narratives
• Arrange and lead Advisory boards across GCC collecting valuable insights about disease area prevalence , incidence , diagnoses and management protocols
• Internal readiness for commercial, marketing and market access team by regular medical training and knowledge assessment tools
• Pharmacovigilance related activities handling end to end process of Risk minimization measure for established products and new launches
• Support with Corrective Action/ Preventive Action implementation, procedural document review from Subject Matter Experts and Area leads - depending on topic

Key achievements in the Medical Advisor role

• Creation of 1st digital national registry for Pulmonary Hypertension using international certified tool PAHTOOL across 7 centers
• Support the publication of SAUDIPH data the 1st internationally published data about PH incidence, prevalence and patients’ demographics in Saudi Arabia
• Conducting 1st virtual forum for pulmonary hypertension in emerging markets
• Supporting mega projects for creation of local guidelines for diagnosis and management of pulmonary hypertension in Saudi Arabia
• Establishment of Local Masterclass in collaboration with top centers of excellence for training of raising stars from across GCC.

• Leading team of 2 District Managers and 4 KAMs
• Execution of Strategic business plans for developing and shaping PH market in Saudi Arabia and position Actelion Pharmacuaticals as world leader in PH through Patient Centric approach
• Mentor Develop and Lead Saudi team for implementing company global medical and marketing strategy and achieving company objectives
• Facilitate Patients Early Access programs for newly approved PH medications.
• Support team for Formulary addition for newly launched product
• Follow Up institutional sales via National tenders "NUPCO " and direct purchase

Key achievement milestones

➢ Strong launch for Actelion portfolio in Saudi Arabia and becoming market leaders in Pulmonary hyoertention

➢ Overachieving company objectives for 7 years in raw within assigned budgets

➢ Inclusion of all company products in all major institutions

➢ Addition of strategic items to NUPCO tender and MOH formulary in a pre-registration strategic step