Marwa Alkafaji

Regulatory Affairs Specialist | NovoNordisk

• Supported product development by providing comprehensive guidance on applicable regulations throughout the process, ensuring adherence at every stage.
• Maintained meticulous records of all regulatory activities, enabling swift access during inspections or audits.
• Reviewed advertising materials before release to ensure claims were backed by scientific evidence, minimizing potential legal risks.
• Enhanced regulatory compliance by developing and implementing robust policies and procedures.
• Evaluated new business opportunities from a regulatory perspective, offering valuable insight into potential challenges or benefits.
• Contributed to successful product launches by coordinating with various departments to ensure all necessary approvals were obtained beforehand.
• Analyzed competitor data, staying informed about industry developments that could impact current or future products.
• Advised executive management on the strategic direction of regulatory activities, incorporating both short-term and long-term goals for the company.
• Prepared and submitted regulatory file applications and supporting documentation.
• Interpreted regulatory rules or rule changes and communicated them through corporate policies and procedures.
• Wrote or updated standard operating procedures, work instructions, or policies.
• Coordinated recall or market withdrawal activities as necessary.
• Provided pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
• Performed and documented quality control checks to maintain compliance with company initiatives.
• Implemented regulatory guidance procedures for EMA as Iraq HA followed it.
• Prepared and maintained document inventory for core dossier preparation.
• Recommended improvements to processes.
• Reviewed all data to assess compliance with company and HA regulations.
• Utilized Veeva Vault system to create product technical file packages and archive all regulatory documents.
• Prioritized project-related tasks to efficiently complete essential tasks.
• Received, researched, and resolved consumer inquiries.
• Provided training to colleagues on regulatory requirements, resulting in increased awareness and overall compliance within the organization.
• Ensured consistency in product labeling by reviewing and approving label designs and promotional materials with local systems and PomoMats.
• Streamlined internal processes for timely submission of regulatory documentation to authorities.
• Collaborated with cross-functional teams to develop risk mitigation strategies, reducing potential non-compliance issues.
• Facilitated productive communication between company management and regulatory agencies, fostering positive relationships.

E-Health Information Manager | Médecins Sans Frontières (MSF)

• Defined, coordinated, and monitored all data-related activities, including data collection, analysis, reporting, utilization, information and patient flow, and monitoring and evaluation processes for a new Hospital Information System / Electronic Medical Record, in accordance with MSF protocols, standards, and procedures.
• Ensured quality medical care for patients and strengthened clinical services, laboratory, pharmacy, radiology, and supply chain management by processing raw data to improve problem-solving, decision-making, and care delivery.
• Promoted effective organization, analysis, management, and use of information in healthcare.
• Created, reviewed, and adapted data collection tools according to project indicators, and coordinated the development, implementation, and follow-up of Standard Operating Procedures (SOPs) for documentation.
• Developed and implemented data quality assurance methods to ensure good performance of activities and reliability of information, while treating all patient information with respect and confidentiality.
• Developed data-driven solutions to facilitate decisions and actions.
• Improved and stabilized medical data collection systems, managed ongoing enhancements of the hospital information system, established reporting frameworks, and facilitated feedback to clinical and programmatic teams for ongoing improvement.
• Facilitated communication and translation of requirements between internal and external stakeholders to streamline patient and information flow through strategic data analysis.
• Provided technical support and training to medical and administrative teams in the implementation of point-of-care data recording, collection, and entry of patient information into the hospital information system.
• Organized and implemented or provided technical support in the establishment of monitoring tools for new activities initiated in the project.
• Managed and supervised work related to quality assurance, including identifying training needs and providing coaching for medical and paramedical staff on data-related issues.
• Implemented detailed analysis of recorded data for key indicators on a monthly, quarterly, or as-requested basis to facilitate the definition, redefinition, or reorientation of project activity.
• Identified and reported any new and interesting indicators for review with the medical team for potential follow-up where relevant.
• Participated in meetings and/or trainings as requested, including MSF internal meetings and/or trainings, and local, regional, or international meetings and/or trainings.

Mission Pharmacy Manager | Médecins Sans Frontières (MSF)

• Supported the Head of Mission and Medical Coordinator in representing and defending MSF's interests before the Ministry of Health and other local authorities or suppliers for any issues concerning pharmaceutical supply, ensuring stock procurement in projects while complying with national laws, regulations, and MSF protocols.
• Ensured close follow-up of the National Drug Supply, particularly in projects where MSF collaborated with the Ministry of Health.
• Collaborated in budgeting and preparing drug and other medical material orders in conjunction with Medical and Logistic Coordinators.
• Supervised the operation of pharmacies across the mission, ensuring proper implementation of MSF Safety standards, including Pharmacovigilance follow-up, waste management protocols, and compliance with national and international legislation.
• Supported and participated in all drug and medical material supply processes, ensuring overall efficiency and effectiveness.
• Followed up with the Ministry of Health during the importation of international orders, closely monitoring the entire process of registration and quality control testing for all medical items (drugs, equipment, lab items, etc.).
• Planned and supervised, in close coordination with the HR department, the associated processes (recruitment, training/induction, evaluation, potential detection, development, and communication) of the staff under his/her responsibility to ensure both sizing and the required knowledge level.
• Participated in reporting according to MSF guidelines (SitReps, medical statistical reports, etc.) and reported on drug consumption and medical devices dispensed according to protocols, informing on unusual patterns.

• Monitoring quality of service offered
• Understanding financial background of the center
• Marketing, handling public relations and observing employees
• Creating procedures for dealing with patients
• Following up implantation of new electronic health information system in the center.

• Dispensing drugs to patient, Major advisory roles to physicians to avoid over prescribing the antibiotics
• Direct supervising of all dispensing drugs to the patients in the hospital
• Regular reviewing of all control release drugs
• Make tour with the doctor in lobbies patients and gave notes about the best drug and doses.
• Enhanced clinical pharmacy services through the development and implementation of evidence-based protocols and guidelines.
• Developed strong relationships with healthcare providers, facilitating communication and collaboration for better patient care coordination.
• Assisted with the development of institution-specific order sets to standardize prescribing practices throughout the hospital system.

• Responsible of selling and marketing of pharmaceutical drugs
• Performs one to one meetings with doctor & pharmacist
• Monitors the supply of drugs as well as inform doctor and pharmacist of for the coming changes
• Introduce new products of the company.
• Analyzed market to identify new opportunities and strengthen relationships with hospitals, medical centers and primary provider physicians.
• Continuously updated knowledge of industry trends and advancements, ensuring an ability to provide clients with the most up-to-date product information and solutions.
• Recognized trends within territory and industry to create proactive plans.
• Arranged appointments with doctors, pharmacists and medical teams to raise awareness of latest product launches.
• Analyzed customer feedback to identify areas for improvement in service delivery.

• Dispensing drugs to patients
• Placing monthly orders for all necessary supplies
• Receiving and classifying all drugs
• Checking all prescriptions for correct dosage and for any potential drug interaction problems
• Patient education and advice as to the proper use of medicines.
• Enhanced pharmacy efficiency by implementing new workflow processes and inventory management systems.
• Mentored and trained new pharmacists and pharmacy technicians, fostering a supportive work environment focused on professional growth.
• Assisted in the development of policies and procedures related to pharmacy operations, promoting compliance with legal regulations and best practices.