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Summary

10+ years experience in the life-Sciences/Pharmaceutical Industry and in global medical and scientific affairs. versatile professional with experience in a wide range of Therapeutic Areas including analgesics, vms, gi and Dermatology. demonstrated ability to work in a global multi-cultural environment across europe and lead highly professional high-performing teams. core skills and competencies: new Product Development, dcp/mrp, Clinical trials, Drug Safety, kol management, global medical affairs, scientific Publications, pr and crisis management, written and oral medical Communication, prescription and otc medicinal products, Medical Devices, Food supplements

Experiences

Current Experience

  • Global Medical Science Lead - Analgesics


    Since September 2015
    senior medical affairs manager leading the analgesics medical science team at rb, covering otc and prescription medications as well as Medical Devices. main responsibilities: - scientific and medical team lead for the analgesics therapeutic area - Research and Documentation on analgesics - investigation of new Health benefits, technologies and ingredients - medical, clinical and development Strategy for analgesics therapeutic area - scientific and medical networking with kols and leading rb medical scientific activities in the analgesics therapeutic area (including advisory boards, attendance to and organisation of scientific conferences and symposia, oral/poster Presentations and publication Planning) - medical sign off of regulatory documents (ctd dossier sections 2.5, 2.7 and 5, rtqs, rfis, reclassification overviews) - medical sign off of Drug Safety related documents (psurs, dsurs, pbrers, ccdss) - representing rb from medical and clinical perspective at regulatory scientific advice meetings (e.g. bfarm, mhra, tga, mcc, swissmedic) - scientific and medical input on design and investigators for company’s sponsored and Investigator sponsored phase 1-4 Clinical trials (including ibs, siss, synopsis, science)" rel="nofollow">Protocol, csrs) - medical oversight and medical monitoring of Investigator and company sponsored Clinical trials Senior medical affairs manager leading the analgesics medical science team at RB, covering OTC and prescription medications as well as medical devices. Main responsibilities: - Scientific and medical team lead for the analgesics therapeutic area - Research and documentation on analgesics - Investigation of new health benefits, technologies and ingredients - Medical, clinical and development strategy for analgesics therapeutic area - Scientific and medical networking with KOLs and leading RB medical scientific activities in the analgesics therapeutic area (including Advisory Boards, attendance to and organisation of scientific conferences and symposia, oral/poster presentations and publication planning) - Medical sign off of regulatory documents (CTD dossier sections 2.5, 2.7 and 5, RTQs, RFIs, reclassification overviews) - Medical sign off of drug safety related documents (PSURs, DSURs, PBRERs, CCDSs) - Representing RB from medical and clinical perspective at regulatory scientific advice meetings (e.g. BfArM, MHRA, TGA, MCC, SwissMedic) - Scientific and medical input on design and investigators for company’s sponsored and investigator sponsored phase 1-4 clinical trials (including IBs, SISs, synopsis, protocol, CSRs) - Medical oversight and medical monitoring of investigator and company sponsored clinical trials

Past Experience

  • Senior Global Medical Strategy Lead - Analgesics

    September 2014 --- August 2015
    medical affairs manager giving strategic medical and scientific direction in analgesics therapeutic area covering otc and prescription medications as well as Medical Devices. main responsibilities: - scientific and medical team lead for the analgesics therapeutic area ????- Research and Documentation on analgesics ????- investigation of new Health benefits and ingredients ????- medical Strategy for analgesics therapeutic area and contribute to overall medical Strategy for other Therapeutic Areas ????- scientific and medical networking with kols ????- medical sign off of registration dossiers ????- medical sign off of Drug Safety related documents (psurs, dsurs, pbrers, ccdss) ????- scientific input on design and investigators for company’s sponsored and Investigator sponsored Clinical trials - Publications ????- medical oversight and medical monitoring of Investigator and company sponsored Clinical trials - claim substantiation - switches

  • Global Medical Manager - Analgesics

    January 2014 --- September 2014
    medical affairs manager in analgesics therapeutic area covering otc and prescription medications as well as Medical Devices. main responsibilities: - scientific and medical team lead for the analgesics therapeutic area ????- Research and Documentation on analgesics ????- investigation of new Health benefits and ingredients ????- scientific and medical networking with kols ????- medical sign off of registration dossiers ????- medical sign off of Drug Safety related documents (psurs, dsurs, pbrers, ccdss) -???? scientific input on design and investigators for company’s sponsored and Investigator sponsored Clinical trials - Publications ????- medical oversight and medical monitoring of Investigator and company sponsored Clinical trials - claim substantiation - switches

  • Global Science Manager

    November 2010 --- December 2013
    medical affairs manager in nutritionals therapeutic area covering Food supplements, otc and prescription specialty vitamins and minerals with global footprint. main responsibilities: - scientific and medical evaluation of vitamins, minerals, trace elements, herbal and other ingredients used in dietary supplements ????- Research and Documentation on Nutrition and Health ????- investigation of new Health benefits and supplement Formulations ????- scientific and medical networking with kols ????- medical sections of registration dossiers (otc and Food supplements) and claim substantiation ????- medical sections of Drug Safety related documents (psurs, dsurs, pbrers, ccdss) ????- scientific input on design and investigators for company’s sponsored and Investigator sponsored Clinical trials ????- medical oversight and medical monitoring of Investigator and company sponsored Clinical trials ????- medical and clinical Due Diligence

  • Scientist

    November 2007 --- October 2010
    - Research in the areas of nutrigenetics and nutrigenomics ????- external Project Management ????- authoring scientific Publications ????- presenting scientific data in congresses and scientific meetings ????- representing the company in scientific associations ????- reviewing and authoring Intellectual Property ????- medical oversight and medical monitoring of Investigator and company sponsored Clinical trials -???? medical and clinical Due Diligence ????- Clinical trial management

  • Post doctoral researcher

    September 2006 --- October 2007
    post doctoral Research on nutrigenetics and nutrigenomics, main responsibilities: - Research in the areas of nutrigenetics and nutrigenomics - external Project Management ????- authoring scientific Publications - presenting scientific data in congresses and scientific meetings - representing the company in scientific associations ????- reviewing and authoring Intellectual Property

Personality

Self Assessment :
Analytical thinkingApproachabilityAttention to detailCollaborationCuriosityFlexibilityIndependenceInterest in knowledgePerspectiveProblem solvingSelf-confidenceStrategic thinking

Knowledge

Self Assessment :
Biostatistics Phase I Scientific writingActions and modes of action of human physiologyAdverse Events (AE)BioavailabilityBioinformaticsBiologyClinical DevelopmentClinical researchClinical pharmacologyClinical Study DesignClinical study reportsClinical trial designClinical trial managementClinical trialsCommunication SkillsDrug DevelopmentDrug regulatory authoritiesDrug Safety and PharmacovigilanceDrug safety assessmentDue DiligenceEarly development stageeCTDEfficacy trialsGeneticsGood Clinical Practice (GCP)Good Publication Practice (GPP)HealthcareICH guidelinesIn vitro diagnostics (IVD)InflammationKOL managementLeadershipLicensingLife SciencesmanagementMedical affairsMedical DevicesMedical writingMedicineMicrosoft OfficeNew Drug Application (NDA)OutsourcingPharmaceutical IndustryPharmacokineticsPharmacodynamicsPhases of clinical development (phase I to IV)Registration of the productScientific Communications
LinkedIn Assessment :
GeneticsPharmaceutical IndustryClinical trialsBiotechnologyLifesciencesBiochemistryClinical researchClinical DevelopmentResearchDrug DiscoveryMedical affairsBioinformaticsNutritionpharmacologyMedical DevicesGCPGood Clinical Practice (GCP)Patentsmolecular biologyStatisticsProduct developmentCell CultureCell biologyScientific WritingMedical writingRegulatory submissionsNutraceuticalsOTCRXSwitchesCTDPSURsPK/PDPain ManagementFood SupplementsMedicalmanagementLeadershipHealthcarescienceLife Sciences

Skills and Expertise

Self Assessment :
Analytical skills Develop clinical trial protocols Assure medical quality Analyze data Develop protocols Interact with physicians Interpret data Report data Search literature on clinical trials Write papers Write protocolsAdvise on medical perspectivesAdvise on strategyAssess adverse reactionsAttend at steering committee meetingsAttend investigator meetingClinical data collectionConduct literature searchesConduct post-marketing surveillance studyConduct research at universitiesData miningDesign clinical trialDesign protocolDesign scientific experimentsDesign studiesInteract with KOLInteract with regulatory stakeholdersInterpret dataInterpret scientific dataLate-stage regulatory filing (MAA, BLA)Manuscript preparation and reviewOral presentationPeople managementPrepare manuscriptPrepare regulatory documentsPrepare responses to health authority queriesProvide benefit risk assessmentProvide medical content for clinical development planProvide medical insightsRegulatory submissions

Education

  • PhD in Clinical Genetics from Erasmus University Rotterdam in 2005
  • MD in Medicine from in 2000

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Professional Proficiency
English
Full Proficiency
German
Professional Proficiency
Turkish
Native

Work Preferences

  • Positions I am interested in:
    Medical Director
  • Positions I am NOT interested in:
    Medical Science Liaison (MSL) Medical Advisor Medical Affairs Associate
  • Locations I am interested in:
    Germany Netherlands Switzerland United Kingdom
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

United Kingdom

Others

Driving License
  • Yes

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