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Summary

Medical doctor with MBA, Bio -Pharmaceutical – CRO expertise in Medical Affairs, Clinical Project Management, Pharmacovigilance, Compliance, Training, and Quality. Lead different positions in Multinationals and contributed to their persistent growth. The growth results achieved by efficient activities used, industry gained experience and leadership skills applied to motivated team, who distributed quality scientific services to specified customers. Therapeutic areas of expertise are: Oncology-Hematology – Psychiatry- Pain- Dermatology – Gynecology – Internal Medicine & Immunology.

Experiences

Current Experience

  • Senior Consultant
    Since June 2015

    Freelance Consultant

    Design & Execute specialized projects (per ICH-GCP- EMA-FDA or local regulations) in the fields of clinical research, medical affairs, Pharmacovigilance, data management to support Bio-Pharmaceuticals, CROs, and health care quality services. The Scope of clinical services includes but not limited to management of :- Project overview discussion, timeframe, budgeting, risk plan, monitoring plan, key milestone deliverables, quality supervision, CRO negotiation, protocol development, writing, site feasibilities, evaluation, recruitment, monitoring activities, data quality, verification, query solving, reports finalization , filing , archiving, quality audit ,CAPA preparation and resolution

Past Experience

  • General Manager ( Mission )
    January 2015 --- May 2015

    Develop and guide the organization strategies for growth, expanding operations and to maintain profitability.Champion the communication processes and drive customer negotiation including proposals, offers and budgets. Provide management support, coaching, and leadership skills to all functional areas heads in clinical operations, data management, pharmacovigilance, medical, regulatory, training, and business development to deliver quality projects in time. Achieved license renewal, targeted revenues, and KPIs

  • Head of Medical Affairs NAF Cluster ( Egypt - Libya - Jordan - Sudan )
    December 2006 --- May 2014

    Ensure that activities were conducted as per GMP, ICH-GCP, EMA, FDA guidelines. Design & lead the company therapeutic area training, SOPs, Policies, Processes, WI for PV, quality, compliance, and medical affairs were effective, valid and in place as per J&J quality standards. Mastered the services of QPPV, PV officer, quality responsible person, compliance- business integrity officer, and clinical trials lead. Liaison and reference contact person between the external and internal stakeholders for related areas of responsibility. Define unmet medical needs, opportunities, improve quality submission approvals processes, and facilitate new products early access. Developed organized Department as per J&J Standards. Coach & supervised team of: MSLs, Admin, MI, ME, PV officer. Launched new Janssen products in Oncology – Hematology – Immunology – Diabetes and CNS with persistent DD growth

  • Quintiles Representative for Egypt & Middle East COH
    February 2004 --- November 2006

    Set business development strategy for Quintiles expansion and business plan discussion. Lead the project development, proposal with budget discussions, training, and coaching as per ICH-GCP. Liaison with stakeholders to develop protocol concepts, final protocols discussion until submission and regulatory approval. Secure safety, monitoring and risk mitigation plans for achieving the quality excellence metrics, performance, resource optimization, and profitability results. Clinical project PV management including regulatory submission & quality issues handling. Motivate and follow up with participants on filing, archiving, and center management on timely quality deliverables. Pursue leadership at different levels of project progress toward best practices and act as an operational expert for ICH –GCP

  • Clinical Research Manager
    September 1999 --- July 2003

    Fostered all processes for completion of all Janssen international projects (phase II-IV trials) from protocol development discussion until final CT report publications in different therapeutic areas (Oncology – CNS – IM- Derma- Gynecology) as per J&J quality standards for ICH-GCP , EMA , FDA regulations. Achieved multiple regulatory & corporate internal QA audits for all executed projects without major observations

     

Personality

Self Assessment :
Analytical thinkingAdaptabilityAssertivenessAttention to detailCollaborationCommunicativeCreative thinkingCritical thinkingCoordinationFlexibilityOrganizationProactivityOptimismStrategic thinkingResult OrientedReaction to stressPerspectiveTrustInterest in knowledgeInnovative thinkingEmotional reactivity

Knowledge

LinkedIn Assessment :
Medical affairsClinical trialsPharmacovigilancePharmaceutical IndustryoncologyNeurologyPharmaceuticsCROClinical researchPharmaceutical salesProduct launchCardiologyDermatologyMarket accessMedicineDiabetesSales EffectivenessPsychiatryHospital SalesClinical DevelopmentTherapeutic AreasUrologyRheumatologymanagementICH-GCPMedical writingDrug SafetyHematologyInfectious diseasesRegulatory affairsClinical monitoringRegulatory submissionsBiotechnologypharmacologyEndocrinologyNephrologyDrug DevelopmentHealth EconomicsMedical EducationKOL developmentPharmacoeconomicsMedical ComplianceStandards ComplianceImmunologyGastroenterologyMedical DevicesMedical TerminologySupervisory SkillsHospitalshealthcare compliance

Skills and Expertise

Self Assessment :
Assure medical qualityAnalyze data/information to determine potential relationships.Analyse growth / improvement potentialApprove monitoring reportsAttend at steering committee meetings Monitor a clinical study Design case record forms Build the CMC development plan Build and manage the Trial Master File (TMF)Act as the main line of communication between the sponsor and the investigatorAdvise on medical perspectivesApprove Label Master SheetApprove consent documentsArchive study documentsAssemble regulatory applicationsArchive trial documentation and correspondence.Collaborate with medical teamComplete case report form (CRF)Communicate with sponsorCommunicate with investigatorConduct post-marketing surveillance studyContribute medical, clinical expertise and scientific advice to all allied departments in local affiliate in particular support to the local clinical development team for timely execution of studies conducted in the affiliate and to DRA in interactions with authorities.Coordinate with the ethics commiteeCreate clinical documentsFacilitate sponsor monitoring visitsImplement Key Performance Indicators (KPI's)Implement Quality Management System (QMS)Informed consent processLiaise with research teamMaintenance of biomedical equipmentManage Clinical Trial Management System (CTMS) Manage clinical trial files/documentsManage research projectsManage regulatory activitiesManage study budgetManage subject consent formmanaging a small teamManage vendor budgetsManage trial master file (TMF)Manuscript reviewMarket approvalMonitor Key Performance Indicators (KPI's)

Education

  • MBA in Business Administration and Management, General from ESLSCA Business School in 2002
  • MB,Bch- MSc -DU in General surgery & Urology from Cairo University Egypt in 1991

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    Medical Manager Medical Affairs Associate Medical Advisor Medical Science Liaison (MSL) Associate Director Clinical Operations Clinical Project Manager (CPM) Clinical Operations Manager Clinical Research Coordinator Clinical Research Manager Clinical Safety Associate Clinical Trial Coordinator (CTC) Global Clinical Project Manager (GCPM, GTM) Senior Clinical Project Manager (CPM) Senior Clinical Research Associate (CRA)
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    50-75% FTE
    BrightOwl freelancer :    30 Hours per week
  • International:
    Yes

Area / Region

Medford, MA, USA

Others

Driving License
  • Yes